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141. Mail order Internet Other FA What went wrong with the device when did this happen Where is the device now Was anyone injured y n Gf yes was the injury Death Serious Minor Please describe the injury and the person who was injured Attach file 122 3 3 16 About us How we regulate In Safety information Swine flu information Safety warnings alerts and recalls General safety information and advice How we monitor the safety of products Reporting safety problems gt Medicines gt Devices gt Blood Information for healthcare professional specialties 2010 Crown Copyright Terms and conditions 020 7084 2000 General enquiries Conferences amp Safety information Learning Centre Committees Online services Publications MHRA News Centre Site Search Advanced search Your views Home gt Safety information gt Reporting safety problems Reporting safe
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181. Field Safety Corrective Action MEDDEV2 12 1rev6 152 AR 3 3 38 Report Form Manufacturer s Incident Report Medical Devices Vigilance System MEDDEV 2 124 rev 5 1 Administrative infor ration Recipient of national competent author HLA Address of national competent authion Date of this PETS number assigned hr 0 Reference number assigned bw N Oto whom zen noun ype af repo Init al report Follow up report Combined initial and final report Fi Death unantcpated serious detenoraton in state of health serious public health thre at All other reportable incidentes Manufacturer Authorised representative within EEA and Switzerland Others identify the role 3 Manufacturer infor mation ANUT ACT i anutacturerz conta peron Postal cade 4 Authorised Representative information Name ofthe authorised representative contact peron 153 5 Submitter s infor mation if dfferent from section 3 4 ubmirtters
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185. Mame oT the amp person m 03 3 m dew ce infor mation ass Active implants MBO Class 111 WD Annex List A MOG Class Ib MD Annex Il List B MOG Class WD Devices forselt testing MOD Class MD General Ao mend ature em preterble mend anre code mend te ommercdal namebrand name make Model and ar catalogue number enal numbers andor lob batchi numberms wersion number it applicable anutactunng date expire date f applicable Accessprneslassaciated device f applicable body CHE ID number T Incident information User report reterence number if applicable d anufacturere awareness date L ate of INGO ent Occurred 154 Number patent Got Humber of medical dew ces involved OT known dewce currentlacation 0 LI inital use O reuse of a single use medical device O reuse of a reusable medical device re zerriced refurbished O other please specify problem noted prior use 8 Patient information Patent outcorme Remedial action taken by the healthcare elevant to the care ofthe pate Age of patent at the ofinaddent f applicable ender if applicable O Female reight in kilograms t applicable HealtFeare facility information Mame ot the healthcare tac ontact person vathin th
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192. i 3 Q a Jump to main content a A gt EN gl Incident Reporting Home Contact us Incident Reporting Home User Reporting Back to MHRA About you There are small number of fields marked with an asterisk These fields must completed before submitting the form About you About the device About what happened Submit Form Title Opr Ms Other Your name Your address Your telephone number Your e mail address This address will be used to send you a copy of your report This will be in a printer friendly format We have a specific form for reports about breast implants Is your report about a problem with breast implants r Q Yes No Freedom of information Adverse Incident Centre 020 7084 3080 aic mhra gsi gov uk A 2009 Crown Copyright To contact us about this website use our feedback form INVESTOR IN PEOPLE Jump to main content Incident Reporting Home Contact us Incident Reporting Home User Reporting Back to MHRA About the device There are a small number of fields marked with an asterisk These fields must be completed before submitting the form About you About the device About what happened Submit Form Kind of device Name of where you got device Name of device Address if known or model number Name of manufacturer Telephone if known Device serial number Name of person if known Have you contacted t
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197. the Description and justin caton o he achon core dwepreventwe utar and the user B Field Safety Notice F SM in English O FSW in natianal language O Others please spedty s 158 Ime schedule tor the implementation of the ditterent actions 1 E J ze J atte qo r ese counties mithin the Within EEA and Sutzed and AT O BE O DU O CY O DE O EE OES O FI O FR O B O GR O HU 15 O LI LT O Lu OLY L MT HL HO FT L RD BI Candidate Countries 0 CR O AI EEA Candidate Countries and Others These counties outside the EEA and Switzedand are affected by this FSCA affirm that the infomation given abowe is correctto the best of my knowledge Signature i Date Submision of dis repart does mat imitsel ene sent a conclu son By the autiros ze rene ie malional moeni authosty that te comtent oz dis moor is complete oracourale that the medica de wce siste Jailed im amy Ar amer am irat dre meiega device s caused arco to de alleged death ardetesom on im fe of health of amy nersam 9 National Supervisory Authority for Welfare and Health National
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203. 3 3 21 Figure 6 Investigation level assigned as percentage 2006 2008 100 909 60 40 20 0 2006 2007 Year min depth Standard E Information o Others knowns echoes non MHEA investigations and reports not concerning medical devices 130 2008 128 8 3 3 22 3 3 22 2006 136 27 MHRA MDA Medical Device Alerts immediate MDA Action CA Notification 2006 D 2008 2009 1 3 3 23 3 3 23 Immediate action Immediate action update Action Action update Figure 10 Medical Device Alerts and CA notifications issued 2006 2008 100 80 60 40 Number of notices 20 MDA Immediate MDA Action CA Notification Type of notice 131 CA GHTF
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207. E Medical Device Recalls Microsoft Internet Explorer RED FTV BALANS YKD ALP O O MAD Dem e 9 0 3 PELAGO http www accessdata fdagov scripts cdrh cfdocs cfRES res cfm UD gt 5 Department of Health amp Human Services www hhs gov FDA u s Food and Drug Administration Search E Medical Device Recalls FDA Home gt Medical Devices gt Databases E CORE 51009 Registration amp Listing Adverse Events PMA Classification CLIA SuperSeareh CFR Title 21 Advisory Committees Assembler Recalls Guidance Standards Medical Device Recalls Help More About Medical Device Recalls Product Name Recall Class Als Date Initiated to Reason For Recall Recalling Firm Sort By Date Record Created descending For full text search select Go 7o Simple Search button This database contains the classified medical device recalls since November 1 2002 10 Records per Go to Simple Search Page Last Updated 07 31 2009 Home About FDA Contact Us Ato Z Subject Index Web Site Policies FOIA Accessibility No FEAR Act 116 2 MEDDEV MEDDEV2 12 1r
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212. 3 3 35 E swissmedic Swiss Agency for Therapeutic Products Archive R ckrufe Medizinprodukte Microsoft Internet Explorer PHO RD RTV AIF Q CO yarn OBS 0298 3 PELAO http wwwswissmedic ch rueckrufe medizinprodukte archiv index html lang en RlArchiv 201 0 01 v EJ Uo ei e swissmedic Swiss Agency for Therapeutic Products Sitemap Index FAG Contact arch Advanced Search De Fr t En Latest news Swissmedic Licences Authorisations Market surveillance Legal matters Data on therapeutic products Human medicines hehe Veterinary medicines Blood and blood Archive Ruckrufe Medizinprodukte components 01 01 2010 30 06 2010 01 07 2009 31 12 2009 01 01 2009 30 06 2009 01 07 2008 31 12 2008 Materiovigilance 01 01 2008 30 06 2008 Recall list Overview 01 07 2007 31 12 2007 Recall list of medical 01 01 2007 30 06 2007 devices 01 07 2006 31 12 2006 01 01 2006 30 06 2006 01 07 2005 31 12 2005 Medical devices Overview Guide Search for recalls New information on medical devices Questions on delimitaton Datum Date Hersteller Handelsname Nom commercial Beschreibung des Information Swissmedic Ref i Fabricant Produktes Description Pandemic portal e produit _ 18 01 2010 Roche Diagnostics Accu Chek Inform Il blood glucose Glucose rapid test
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218. all months all years Help viewing PDFs Download documents Help viewing PDF files Download Acrobat Reader for tj Medical Device Alert Powerheart free AED G3 and automatic Adobe text conversion tools extemal defibrillators AEDs manufactured by Cardiac Science f 2010 2 8 10 18 O g DLF Disabled Living Foundation http www dlfLorg uk B E DLF DLF Ask SARA IDLF DATABASE The Information Standard 1969 1971 DLF DLF daily living equipment
219. medical devices Drug Alerts Safety warnings and messages for medicines General safety information and advice How we monitor the safety of products Reporting safety problems Information for healthcare professional specialties Section search Enter keyword or phrase to search all pages in this section Search this section Advanced search Global Harmonization Task Force 3 3 24 MDA Home Pharmaceutical industry Contact us FAQs Conferences amp Learning Centre Publications Safety information Committees Online services Glossary Sitemap Site Search News Centre AZ index Access keys Help Advanced search Your views Home gt Safety information Medical Device Alerts Medical Device Alerts Safety warnings alerts and recalls Medical Device Alerts MDAs were introduced on 01 January 2003 to replace the previous types of safety warnings Hazard notice Safety notice Device alert Advice notice and Pacemaker technical note which can be found under Publications Safety warnings MDAs are distributed to the NHS in England via the Department of Health s Central Alerting System CAS MDAs remain valid unless they are updated or withdrawn They are reviewed once they are five years old and subsequently every year and the lists on this website are amended accordingly Latest Medical Device Alerts 18 Feb 2010 Med
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221. Authorisations Market surveillance Legal matters Data on therapeutic products Legal matters Home gt Market surveillance gt Medical devices gt Recall list of medi gt Search for recalls Human medicines Veterinary medicines Blood and blood Search for recalls components Medical devices Keyword Overview Guide Materiovigilance Recall list Overview Recall list of medical devices Archive Search for recalls New information on medical devices Questions on delimitaton Pandemic portal Swissmedic Swiss Agency for Therapeutic Products Hallerstrasse 7 Box CH 3000 Bern 9 41 31 322 02 11 F 41 31 322 02 12 Disclaimer E http wwwi swissmedic ch rechtstexte 00201 index html lang en 3 3 37 E swissmedic Swiss Agency for Therapeutic Products Search for recalls Microsoft Internet Explorer FE CE RT BACANA Q CO WAG Per youn eS 1006 3 ELAD http www swissmedic ch rueckrufe medizinprodukte suche index html langzen e swissmedic Swiss Agency for Therapeutic Products Sitemap Index FAQ Contact search Advanced Search De Fr it En Latest news Swissmedic Licences Authorisations Legal matters Data on therapeutic products Human medicines gt Market surveillance gt Medical devices gt Recall list o
222. Does Frequenay amp Route Leed Therapy Caden unknown Give Grace 525 5 CR FRODUCT MO Section forte jor best estimate 1 1 1 Adversa Event andor Product Problem ve dere tima tons 2 Attributes to Adverse Event Check ah that am 4 for Ugs 5 Event Abated ice stopped or Doss Reduosd7 Si Ter Mao Live O Pare et Doeznt 2 B Event Reapnpeasred Ather Reintroducthon Doesnt 1 Clees ru zl 4 8 of Unique ID 10 Conoomiant Medioa Products and Therapy Daer o sereni or Permanent Damage Wu nr Li threatening L Congenital AnomaiyiBirth Detect Hospitalization inital or profonged Bther Serious Important Medical Events Foeuired Intervention In Prevent Permanent imnpalmentDamags Devices 3 Date of Event 4 Dale of This Report momo yryr Decorlba Event or Problem D SUSPECT MEDICAL DEVICE 2 Common Device Names 3 Manufacturer Name Cy ang State Heath Professional Expiration Date mies xci _ If Implanted Give Date mom 23 vyy If Explante amp d Gire Daie B Ir this a Zing Delos tat was Renrooecced and Reucad on a Patlent Ma B to Sem Ho 3 Enter and Addrecr
223. Organisation Address including postcode Telephone number E mail address This address will be used to send you a copy of your report This will be in a printer friendly format Email copy of report to Separate multiple addresses with a comma Local reference number Consultant in charge if known Type of device General Report Form All other devices Artificial Limbs External limb prostheses Position Occupation Reporting Organisation Address including postcode Telephone number E mail address This address will be used to send you a copy of your report This will be in a printer friendly format Email copy of report to Separate multiple addresses with a comma Local reference number Consultant in charge if known Type of device General Report Form All other devices C Artificial Limbs External limb prostheses Orthotic devices Hip or Knee Implants Implantable pacemakers defibrillators In Vitro Diagnostic Medical Devices Wheeled Mobility and Associated Equipment Breast implants Cochlear implants Freedom of information X Adverse Incident Centre 020 7084 3080 Ez aic mhra gsi gov uk we n 2009 Crown Copyright To contact us about this website use our feedback form INVESTOR IN PROFLE 124 Jump to main content Incident Reporting Home Contact us Incident Repo
224. Oro ed to re alleged death ardeterioratioam in the see ofthe health of army nero 156 3 3 39 FSCA Report Form Field Safety Corrective Action Medical Devices Vigilance System MEDDEV 2 1271 57 1 Administrative information Destination erence number er nauarnsai earipeteri authontes this repartuuaz ze 2 Information on S mitter of the report Authorised representative within EES Others Cidentity the rale 3 Manufacturer infor mation d anutacturer name i anufacturers contact person 4 Authorised representative enon Mame ofthe authorized represe autnangzed reprezentative contact 157 5 National contact pont intor mation anon al conta Pant ofthe person edd F ostal Code emm Med cal dew ce information D implants MOD Class 111 MOD Class Class MOD Class MD Annex List A MWD Annex ll List B MD Devices farselt testing WD General Ao meng ature em preferable shill cade mend ature te mme rda numbers andlor ET o oO oware versIon number Manutactunmg datefexping date f applicable ALGCESSOM assoc ted device If applicable Honn ed body ID number T Description af FSCA intamiatian and reason
225. Q gt INVESTOR IN PEOPLE Home Pharmaceutical industry Contact us FAQs Glossary Sitemap 2 index Access keys Help Site Search Conferences amp Safety information Learning Centre Committees Online services Publications News Centre Advanced search Your views Home gt Safety information gt Reporting safety problems gt Devices Reporting adverse incidents involving medical devices This section gives all the relevant information on reporting adverse incidents involving medical devices including details on the updated online reporting system The MHRAS newly updated online reporting system for medical device users was implemented on 8 November 2009 We hope that you will find reporting adverse incidents a simpler and easier process If you have any comments on the new system or if you have any questions about incident reporting please contact the Adverse Incident Centre AIC aic mhra gsi gov uk or 020 7084 3080 The information from adverse incident reports can help identify faults with medical devices and may prevent similar incidents happening again If you have experienced a problem with a medical device please send us the details using one of our online forms We will assess and where appropriate investigate all incident reports that we receive Use our online reporting systems Clinicians healthcare and social care workers If you are a clinician healthcare or social ca
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227. der geanderten Einteilung der Fehlerursachen zu nicht produktbezogen und nicht bekannt nicht feststellbar wird auf die Fu note zur Einzelauswertung Fehlerursachen verwiesen Inhaltliche Anderungen sind damit nicht verbunden Bundesinstitut f r Arzneimittel und Medizinprodukte 1 2 Keine vernachlassigbar Gering Schwerwiegend Kritisch GP Tod unbekannte Sch digung 147 3 3 34 Statistische Auswertung der im Zeitraum 01 01 2005 bis 31 12 2008 abschlie amp end bewerteten Risikomeldungen Ma nahmen zur Schadensbegrenzung f r Produkte im Feld R ckruf gem S 2 Nr 3 MPSV Vertriebsstopp Produktionsstopp Anwendungsstopp Anwenderinformation Mafinahmenempfehlung Anwenderschulung 29 Sonstige 74 0 200 400 600 800 1000 1200 1400 1600 1800 2000 2200 Im Vordergru nd stehende ht mit einer anderen im Vordergrund stehenden Ma nahme verbunden Sofe Stand 09 02 2009 Anzahl der a uswertbaren Risikomeldungen 12925 10384 Risikomeldungen f hrten zu keinen Ma amp nahmen c EE Bundesinstitut f r Arzneimittel u und Medizinprodukte EATM
228. ifzelf represent a conclusion by fhe manufacturer and or authorised representative or fhe Natonal Competent Authority that fhe content af this repart is complete or accurate that the medical device z Irsted failed in any manner and or that the medical devices caused or contributed fo the alleged death or deterioration in the State af the health af any person Signature em affirm that the information given above Is correct to the best of my knowledge send XML data by E Mail 142 d BfArm 2008 5 000 2000 3 3 27 GHTF 248 3 3 28 3 3 29 3 3 30 3 3 27 Informationen uber Risiken durch Medizinprodukte Anzahl der Risikomeldungen Risikomeldungen Gesamtzahl 2000 1934 2001 2019 2002 2266 2003 2535 2004 3097 2005 3387 2
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232. 006 3862 2007 4646 2008 4883 2001 2002 2003 2004 2005 2006 Anzahl der Risikomeldungen Stand 02 02 2009 Bundesinstitut Arzneimittel und Medizinprodukte 1 2 IVD nicht aktive MP aktive MP 143 3 3 28 Informationen ber Risiken durch Medizinprodukte Anzahl der Risikomeldungen 2000 2008 Produktgruppe 2000 Aktive Implantate Injektion Infusion Transfusion Dialyse Nichtaktive Implantate Medizinische Elektronik und Elektromedizin Dentalprodukte OP Ausr stung und An sthesie Orthop die und Rehabilitationstechnik Humanmedizinische Instrumente Physikalische Therapie Ophthalmologische Technik Allg med Behandlungseinrichtungen ger te hilfsmittel Optik Feinmechanik Radiologische Technik Verbandmaterial Unterlagen Empf ngnisregelung Strahlentherapie Strahlenschutz In vitro Diagnostika Elektro Magnetische Felder Ultraschalltechnik Medizinische Datenverarbeitung Software Summe 01 01 2000 31 12 2008 Stand 02 02 2009 1 Vorkommnis ohne Zuordnung Bundesinstitut f r Arzneimittel und Medizinprodukte HE 3 3 29 Statistische Auswertung der im Zeitraum 01 01 2005 bis 31 12 2008 abschlieRend bewerteten Risikomeldungen Q
233. 6 3 24 5 20 4 19 496 31 6 32 7 20 4 15 3 oe 34 3 2 21 N 96 1 2 mee 4n m 3 4 5 1 2
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235. 80 100 4 7 8 0 80 0 234896 81 0 N 50 N 42 0 20 40 60 80 100 4 5 89 7 233 996 61 89 9 3 2 51 ____ __ ___ __ ___ __ __ _ _ _ _ _ _ _ _ __ _ ___ _ _ ___ N 145 VE N 129 0 20 40 60 80 100
236. D APY O HAO ww ymo 68 3 008 http www accessdata fda gov scripts cdrh cfdocs cf MDR Search cfm U S Department of Health amp Human Services www hhs gov FDA U S Food and Drug Administration 2 Index Search Food Drugs Medical Devices Vaccines Blood amp Biologics Animal 8 Veterinary Cosmetics Radiation Emitting Products Tobacco Products FDA Home gt Medical Device gt Databases MDR Database Search GP on 51000 Registration amp Listing Adverse Events Recalls PMA Classification Standards CFR Title 21 Radiation Emitting Products X Ray Assembler Medsun Reports CLIA Search MDR Database Help Download Files More About MDR Enter a search term below and select Search Enter a single word e g catheter an exact phrase e g catheter line or multiple words connected by and e g catheter andtubing To Search by Product Description Manufacturer Report Type Product Code or date select Go 7o Advanced Search button Manufacturer and User Facility Device Experience Search for incidents after July 31 1996 Home About FDA Contact Us Ato Z Subject Index Web Site Policies FOIA Accessibility No FEAR Act Combination Products Advisory Committees Science amp Research Regulatory Information Safety Emergency Preparedness International Programs News amp Events Training and Continuing Education Inspe
237. Deutsch Vk 20091223 08 GmbH meter system analyser Fran ais UPDATE Model 050600303001 05060311001 English Update DE FR EN LL 18 01 2010 Applimed SA Set de pansement pour plaies MD Wound care set Fran ais Vk 20091 222 05 superficiales sterile single use sterile Model 4909942 Lot 05 08 2009 16 08 2009 20 06 2008 24 06 2009 03 07 2009 06 07 2009 20 07 2008 18 08 2009 18 01 2010 Beckman Coulter Access Free Calibrators Free triiodothyronine Deutsch _201 00114_01 Inc Model A13430 kit Frangais Lot 989902 989903 989904 989905 English 989906 989907 18 01 2010 ITD GmbH Compact Cart Bags Deutsch Model TACC51016990 100 Francais S N 51016990 001 English i Adobe Updater x Vk 20091223 13 149 3 3 36 F swissmedic Swiss Agency for Therapeutic Products Search for recalls Microsoft Internet Explorer mef Prove FED RTV HACANA YMD AF HAO desem 683210483 FELAD http www swissmedic ch rueckrufe_medizinprodukte suche index html lang en E ah UD swissmedic Swiss Agency for Therapeutic Products Sitemap Index Contact search Advanced Search Latest news Swissmedic Licences
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242. HEALTHCARE I JOERNS HEALTHCARE J T POSEY CO J T POSEY CO INVACARE CORP INVACARE CORP INVACARE CORP INVACARE CORP Date Report Received 08 30 1996 08 30 1996 08 21 1996 08 21 1996 07 29 1996 07 29 1996 07 19 1996 07 19 1996 05 29 1996 05 29 1996 05 29 1996 05 29 1996 JOERNS HEALTHCARE I MONOTROL HEALTH CARE 05 24 1996 JOERNS HEALTHCARE I JOERNS HEALTHCARE I MONOTROL HEALTH CARE MONOTROL HEALTH CARE 05 24 1996 05 24 1996 JOERNS HEALTHCARE JOERNS HEALTHCARE I EZC 200 ELEC BED Wf EZC 200 ELEC BED Wi 05 24 1996 05 24 1996 3 3 10 MDR Database Search Microsoft Internet Explorer x E FRDO Sri BACANA YD a On O HAD Ds yom 4 LOas D 4 http wmwmaccessdata fdagov scripts cdrh cfdocs cf MDR Detail CF M ID 3090 www hhs gov FDA u s Food and Drug Administration Search E Food Drugs Medical Devices Vaccines Blood 8 Biologics Animal amp Veterinary Cosmetics Radiation Emitting Products Tobacco Products 0 5 Department of Health amp Human Services 2 Index FDA Home gt Medical Device gt Databases MDR Database Search 51009 Registration amp Listing Adverse Events Recalls PMA Classification Standards CFR Title 21 Radiation Emitting Products X Ray Assembler Medsun Reports CLIA gt cone New
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245. RE SE o se Ce amp Even respeaned afar Che Che HEEF lor product probicms ony EE Eh TTT Let enr madieal D Suspect medical device 4 Manuracturer ramas amp Jaiei tagti caberatpry daa nduding dames T relevant history including Prescisling mescal candi lene ten alata pregnancy smoking and Soir use hepaticrenal dysfunction its Submission of a report dass not eanalitute am 2 3 Occupation 4 Initial emporter aiso FIDA admission that medical personnel usar l acillby L pus zl M tj distributor mamuzacburer or product caused or yan na unk contributed bo the evant Pii Forge EDO DS 109 Medication and Device Submission of a report daas not constituta an admission that medical personnal usar Experience Heport facility distributer mangtacturer or product continued caused or contributed to the event Refer to guidelines specilic instructions Page el rem Foruse by user facilityidistributor devices Device manufacturers only 1 Check one 2 UFIDISE reest number Type of repartabis even Z I follow up what typeset distri 7 serious injury additional intormatite matiunetion poser uice ness emacnse s User facility diistriburor mamaigrd ress 3 Danica
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247. Search Back To Search Results INVACARE FULL SEMI ELECTRIC HOME CARE BED INVACARE CORP 899 CLEVELAND STREET ELYRIA OH 44035 BRAND NAME MANUFACTURER ACCESS NUMBER 884941 PRODUCT CODE FNL PANEL GENERAL HOSPITAL REPORT TYPE DEATH DATE FDA RECEIVED 08 30 1996 DEVICE MODEL NUMBER DEVICE CATALOGUE NUMBER EVENT DESCRIPTION TYPE EVENT DESCRIPTION 5310 5310 PRELIMINARY AN ELECTRIC BED WAS INVOLVED IN A MOBILE HOME FIRE WHICH RESULTED IN THE PTS DEATH FIRE INVESTIGATOR CATEGORIZED THE INCIDENT AS ACCIDENTAL IN THE INVESTIGATOR S OPINION THE MOST PROBABLE HEAT SOURCE WAS A SHORT OR ARCING INVOLVING THE ELECTRICAL SUPPLY WIRE FOR THE HOSP BED MOTOR CO HAS NOT DETERMINED THAT CO S DEVICE WAS THE SOURCE OF THE FIRE MFR DATE 1 1 91 114 7 ei FDA II 3 3 11 3 3 11 I
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249. also be reported 120 c MHRA MHRA NHS MHRA lt 2 ERR CHAS eo Ov 3 3 15 3 3 15 reporter s name position occupation Reporting Organization Address including postcode telephone number e mail address local reference number consultant in ch
250. arge If known of devices general report form all other devices artificial limbs external limb prostheses It Ae orthotic devices Hip or Knee implants Implantable pacemakers defibrillators in Vitro Diagnostic Medical Devices Wheeled mobility and Associated Equipment Breast implants Cochlear implants Type of devices Model Manufacturer name Manufacturer phone number Serial number Lot or batch number Date of manufacture Expiry date Quantity defective Enter number not text current location of device Has the manufacturer supplier been contacted y n CE 15 the device CE Marked y n dont know date of incident 121 type of injury death Serious Revision Distress no
251. bunden LJ 4 Bundesinstitut fiir Arzneimittel und Medizinprodukte aud 3 NK Hl 2 Design Konstruktionsfehler Nicht produktbezogene Ursache Ursache nicht bekannt nicht feststellbar 3 3 33 Statistische Auswertung der im Zeitraum 01 01 2005 bis 31 12 2008 abschlieRend bewerteten Risikomeldungen Nicht produktbezogene Fehlerursache Eingetretene Auswirkungen in Verbindung mit einer Meldung Keine vernachlassigbar Befindlichkeitsst rungen vor bergehende leichte Beschwerden Gering vor bergehende Verletzung oder Beeintr chtigung die keine rztliche zahn rztliche Behandlung erfordert Schwerwiegend Verletzung oder Beeintr chtigung die eine arztliche zahnarztliche Behandlung erfordert einschlie lich semikritischer vorzeitiger Explantation Kritisch dauerhafte schwere Beintr chtigung oder schwere Komplikation die eine chirurgische oder intensivmedizinische Intervention erfordert einschlie lich kritischer vorzeitiger Explantation Tod lebensbedrohliche Zust nde mit hoher Wahrscheinlichkeit eines letalen Ausgangs unbekannte Sch digung keine statistische Auswertung Stand 09 02 2009 Anzahl der auswertbaren Risikomeldungen 12925 Hinsichtlich
252. ce failure misdiagnosis due to medical device failure leads to inappropriate treatment a patient s health deteriorates due to medical device failure Causes of incidents involving devices may include design or manufacture problems inadequate servicing and maintenance inappropriate local modifications unsuitable storage and use conditions selection of the incorrect device for the purpose inappropriate management procedures poor user instructions or training which may result in incorrect user practice Conditions of use may also give rise to adverse incidents environmental conditions e g electromagnetic interference location e g devices designed for hospital use may not be suitable for use in a community or ambulance setting The occurrence of an adverse incident may identify the potential for harm even though actual harm has been averted by the timely intervention of healthcare providers or by good fortune The MHRA 15 concerned that users should report all incidents regardless of whether actual harm has or has not been caused There is also a distinction between direct and indirect harm Indirect harm may be caused by a device which does not normally come into contact with patients For example a malfunctioning in vitro diagnostic device such as an automated analyser may lead to delayed or inappropriate treatment of a patient thus causing indirect harm These incidents should
253. co eu an AEN CO amp He E S WO c D Miel NMA Dirt CSS TAAL 9899214 FC BE OS 6 0 CEO OH 2710 Brie G CD c EE Co HABA 2 ooS 0 TERO ANS DAE 8 9 gt BRE MAH E EE SEI Co He HL c D c ex E fy Ig x 1p 38110 10 KY S 713 2 Sahl Si METRO LAL 6 20 0 8 0 2 6 GEES SAY LEY con SC wz CEO TC 27 1 RH lt 001 1 E 000119 THE G4 3 NEU TA Q BIASED 2 915 CIE ee Ov Co ALG LAM DIL 8 0 E lt TIGRE SAY LEY Rio ce 9 271 HAH sS CD RH lt 0 lt 1 YTS LEY 0 08 1 1 rel 2 H r 6 BEA E PME PEST 0 0 xL 8I Diss IE Tf OT 0001 hd E ETE SEP C tbe obt 27 Y1960L CHE 6 HH 61 A Bray ano ae BO t Hee HEET elf SI 6 1 3 zl SOY Sa 20 500 006568 tfl AKEJ TOL TISESP gt Voc vv AL S4 d Co Q 24 G L NM 2 A
254. ctions Compliance State amp Local Officials Consumers Industry Health Professionals http www fda eov Bioloeics BloodVaccines defaulthtm TEE 113 3 3 9 a MDR Database Search Microsoft Internet Explorer E FED ATM D YD AIAH Os O HAO pe O82 m LOS D http wmwmaccessdata fdagov scripts cdrh cfdocs cf MDR Results cfm K 925 Department of Health amp Human Services www hhs gov FDA u s Food and Drug Administration Search Home Food Drugs Medical Devices Vaccines Blood amp Biologics Animal amp Veterinary Cosmetics Radiation Emitting Products Tobacco Products 2 Index FDA Home gt Medical Device gt Databases MDR Database Search 51009 Registration amp Listing Adverse Events Recalls PMA Classification Standards CFR Title 21 Radiation Emitting Products X Ray Assembler Medsun Reports CLIA core 500 records meeting your search criteria returned Please narrow your search New Search Help Download Files More About MDR Brand Name INVACARE FULL SEMI E INVACARE FULL SEMI E INVACARE FULL SEMI INVACARE FULL SEMI NURSING HOME BED NURSING HOME BED POSEY CRISS CROSS VE POSEY CRISS CROSS VE SAFETY BED RAIL SAFETY BED RAIL SAFETY BED RAIL SAFETY BED RAIL Manufacturer Name INVACARE CORP INVACARE CORP INVACARE CORP INVACARE CORP JOERNS
255. d Z VV 16 9 6 7 8 4 46 1 wee 0 39 22 N Ann diih 27 254 E 55 1 3 2 4 1 a 1 7 AF 71 1 64 5 44 71 ovo 52 9
256. d their authorised representatives a simple electronic means of submitting Vigilance reports to the Agency and of providing responses to MHRA incident investigations e Registered Users Registered Users may log in below Not yet registered If you have not yet registered as a MORE account holder click the link above and submit the requested details for verification Please note that the provision of certain information is compulsory for registration On line Help is available if required Forsecurity reasons new accounts will not be activated until registration details have been checked and verified by the MHRA Email Address Account No Password Terms and conditions Privacy policy Freedom of information Adverse Incident Centre 020 70843080 aic mbra gsi gov uk gt 2009 Crown Copyright To contact us about this website use our feedback form Ge INVESTOR IN PEOPLE 127 d MHRA 8 000 2007 79 2 2008 MHRA 3 1 2008 8 902
257. desinstitut f r Arzneimittel und Medizinprodukte http www bfarm de Afssaps Agence francaise de s curit sanitaire des produits de sant http www afssaps fr swissmedic Swiss Agency for Therapeutic Products http www swissmedic ch NAV 7 7 7 95 f t amp WE XH fk Norwegian Labour and Welfare Organisation MPA Medical Products Agency http www lakemedelsverket se National Supervisory Authority for Wealfare and Health http www valvira fi en Kg 7 Danish Center http www hmi dk 2 GHTF Global Harmonization Task Force 3 3 3 Ge ae Es HE wt TTT
258. duct Use Error Relevant Tae story Data Including Dates PLEASE TYPE OR USE BLACK NE 7 Other Relevant History Including Preexisting Medical Conditions alleges race pregnancy smoking and alcoha use pot OTHER CONCOMITANT MEDICAL PRODUCTS Product names and merapy dates exciude Peatment of event Section F Hein page 3 Product Avallabia for Evaluation Do nat send product fo ADA Reumedto Manufacturer onc 2 Health Professional 3 Occupation 4 Also Reported to lees Manufacturer do wand your Identity User Facilty to the manufacturer place an X in th c box Distriburtzramporer FORM FDA 3500 4 09 Submission of a report does nat constitute an admission that medical personnel or product or coniributed to the event 111 TYPE OR USE BLACK INK PLEASE NextPage Reset Form __ Fom Aoi Se l Ge dE U S Department of Health and Human Services dre Mer Report 2 EE ATCH iS MANDATORY pon MEDWATCH FORM FDA 35000 ts elmer Page tr A PATIENT INFORMATION Section A Help C SUSPECT PRODUCT S 1 Patent identifier 2 Age x Time i tan 4 Weight 1 ame Give beled zir ngt amp eater of Ewent LE Femaie Ez xin oF Date 2 In comidsnce of Birth Mae kgs 2
259. e Ta cili ountny 10 Manufacturer s preliminary comments Initial Follow up report Manufacturers preliminary analysis core Awe adinzprnuvenamde acamarz Implemented bw 1 e manta aurer xpected date of nest repo 11 Results af manufacturers final investigation Anal repart manuTactirerz device analysis OTE ebe 072 FOCA the s 5M Bee fom oF Annex d 155 Indl GOMMent Trom trie m investigations the manufacturer aware of similar incide nts with this pe Of medical device azimilar cauze Yes O wes state in which countries and De report reference numbers of the incidents H Within EEA and dand AT BE BU CH L CY cz Dk L EE L ES O FI FR O GR L HU IE 15 O IT L1 LI L LT O LU LV L MT L HL O NO FL O RO L SE 05 OSK Candidate Countries L CF O TE O EEA Candid ate Countries and dand Othe rs 12 Comments affirm that the infomation given abowe iz correctto the best of my knovd edge City Date Sn of ais does enmesent a corel son by the an andar autos zed renresenative or ihe natora that the content or dis moon is complete orac rat that the medica de wee sen Giel im amy ot Stret amr iat he medica de vice s caused
260. ed other problem noted prior use Patient outcome Remedial action taken by the healthcare facility relevant to the care of the patient Gender if applicable Female Male Age of the patient at the time of Incident If applicable units Years months Weight in kilograms tf applicable of the healthcare facility Contact person within the facility ua i us HI 140 10 Manufacturer s preliminary comments Initial Follow up report Manufacturer s preliminary analysis Initial corrective actions preventive actions implemented by the manufacturer Expected date of next report 11 Results of manufacturers final investigation Final report The manufacturer s device analysis results Remedial action corrective action preventive action Field Safety Corrective Action Time schedule for the implementation of the identified actions Final comments from the manufacturer Further Investigations Number of similar incidents If yes state which countries and the report reference numbers of the incidents 141 Far final reports only The medical device has been distributed to the following countries within the and Switzerland BE BG CH CC CZ DE EE TES FR T GB GR 5 it CU CU riu LV PL Tse 5i Candidate Countries HR TR All EEA candidate countries and Switzerland Submission of this report does nat in
261. equently caused bilateral pneumothoraces 01 Feb 2010 Monthly list of MDAs 2010 Printer friendly version new window Related information MHRA pages Advice notices Device alerts Hazard notices Pacemaker technical notes Safety notices Help viewing PDFs Help viewing PDF files Download Acrobat Reader for free Adobe text conversion tools 132 li Home Pharmaceutical industry Contact us FAQs Glossary Sitemap 2 index Accesskeys Help Site Search Home gt Publications gt Safety warnings Medical Device Alerts Medical Device Alert Powerheart AED G3 and CardioVive automatic external defibrillators AEDs manufactured by Cardiac Science Corporation MDA 2010 014 Ref MDA 2010 014 Issued 18 Febr 010 at 14 3 England Northern Ireland Scotland Wales Problem Action Distribution Manufacturer contacts Powerheart AED G3 and CardioVive automatic external defibrillators AEDs manufactured by Cardiac Science Corporatio Specific model numbers affected Powerheart AED G3 9300A iss SC 9300D 9300E Series No MDA 2010 014 9300 us 90A 1883008 CardioVive 92531 92532 and 92 Audience Healthcare professionals Published 18 February 2010 at 14 30 Format Electronic only Size Ad Pages 4 Price Free n ISBN ISSN this Author section Copyright Crown
262. erland Others identify the role 137 3 Manufacturer Information Contact Name Address un 4 Authorised Representative Information Name of the Authorised Representative The Authorised Representative s contact person Address Postal code _ ________ 138 6 Medical device information Active implants MDD Class WD Annex Il List A MDD Class llb C Annex 11 List B C MDD Class lla CVD Devices far self testing C MDD Class C WD General GMDN Nomenclature text Commercial name brand name make Serial number s if applicable Lot batch number s if applicable Software version number if applicable Implant date For implants only Explant date For implants only Duration of Implantation For Implants only To be filled if the exact Implant and explant dates are unknown Accessories associated devices If applicable Notified Body NB ID number 7 Incident Information Incident description narrative User facility report reference number if applicable Manufacturer s awareness date Number of patients involved 1f known Number of medical devices Involved if known d 1 Medical device current locathon disposition 0f known 139 Operator of the medical device at the time of Incident select C Healthcare Professional reuse of a single use medical device reuse of a reusable medical device re serviced refurbish
263. ev6 Gincident2 Vigilance System 1 incident 2 3 MHRA Medicines and Healthcare products Regulatory Agency DLF Disabled Living Foundation 7 MHRA Medicines and Healthcare products Regulatory Agency
264. f medi gt Search for recalls Veterinary medicines Blood and blood Search for recalls components Medical devices Datum Date Hersteller Handelsname Nom commercial Beschreibung des Information Swissmedic Ref Overview D Produktes Description du i oduit Guide E Materiovigilance Russka Ludwig Rollator Nexus 50 MD Walker wheeled Vk 20100126 14 Recall list Overview Bertram GmbH Model 11445 000 EES SIN SN10809 50 bis SN10828 50 ecall list of medical HERES Rollator Nexus 64 Archive Model 11445 020 Tr SN gw 0982 84 bis SN11055 64 und New information on medical devices Rollator Nexus 57 STEN MS bis BN13871 57 und Pandemic portal SN14862 57 bis SN15201 57 19 10 2009 InvacareReaAB REA Azalea Base MD Wheelchair Deutsch Vk 20090728 01 SIN 020808803610 020808077150 020808655668 020809124875 24 08 2009 ConMed Linvatec Bur Diamond Wheel TEAL MD Orthopaedic bur Deutsch Vk_20090812_05 Corporation Model 00702149200 reusable Bur Diamond Wheel LIME Model 00702139200 UltraPower Bur Diamond Wheel RED Model 00702109200 Bur Diamond Wheel MUSTARD Model 00702129200 S N all with expiration dates between July 2008 and April 2013 27 04 2008 Sunrise Medical Powered Wheelchair MD Wheelchair electric Deutsch vk 20090326 04 c
265. he manufacturer Can we contact them Q Yes O O Yes O No Where did you get the device from NHS hospital Nurse Pharmacy NHS clinic Private hospital Shop GP surgery Private clinic Mail order Internet Other please specify If Other please specify 126 Jump to main content Incident Reporting Home Contact us Incident Reporting Home User Reporting Back to MHRA About what happened There are a small number of fields marked with an asterisk These fields must be completed before submitting the form About you About the device About what happened Submit What went wrong with the device When did this happen Day Month Where is the device now Was anyone injured Q Yes If yes was the injury Death Serious Minor Please describe the injury and the person who was injured Attach File Attach file File Name amp Comment Transfer of devices to MHRA MORE Manufacturers Online Incident Reporting Home Contact us Reporting Environment Register In MORE MHRA gt MORE Log in Log in Registration form Welcome to MORE the Manufacturers On line Reporting Environment This system has been especially designed by the MHRA to provide device manufacturers Terms amp Conditions and suppliers an
266. ical Device Alert Powerheart AED G3 and CardioVive autornatic external defibrillators AEDs manufactured by Cardiac Science Corporation MDA 2010 014 This Medical Device Alert MDA has been issued due to a small risk that the AED may not deliver a shock during a rescue attempt because the software self test may not detect a fault with a specific internal component 18 Feb 2010 Medical Device Alert Arjo Passive Clip sling and Arjo Passive Clip Flite slings manufactured by Medibo MDA 2010 013 This Medical Device Alert MDA has been issued due to the incorrect attachment of the sling clips to the spreader bar which can lead to the person in the sling falling out and injuring themselves or others 10 Feb 2010 Medical Device Alert Teligen and Cognis defibrillators specific models manufactured by Boston Scientific MDA 2010 012 This Medical Device Alert MDA has been issued because if these defibrillators are implanted subpectorally there are risks of loss of shock therapy inappropriate shock therapy loss of pacing therapy or loss of anti tachycardia pacing 08 Feb 2010 Medical Device Alert Servo 300 and 900 ventilators SV300 and SV900 manufactured by Siemens now Maquet MDA 2010 011 This Medical Device Alert has been issued due to excessive negative pressures eg using closed suction systems which can damage the inspiratory and expiratory pressure measurement transducers Such damage has led to high gas flows that subs
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268. nation Defizite in der Kennzeichnung und Gebrauchsanweisung Zus tzliche spezielle Fehlerarten bei IVD Medizinisches Erscheinungsbild hilfsweise Multifaktorielles Erscheinungsbild Sonstiges Welches unerw nschte Produktverhalten bzw welche unerw nschte E bestand vor Eintreten der Auswirkung Falls zutreffend kann bei Ausbleibender Alarmierung eine weitere Fehlerart angegeben 3 modifizierte Erfassung seit 01 01 2006 Mechanische Probleme 146 BEA eyi 3 3 32 Statistische Auswertung der im Zeitraum 01 01 2005 bis 31 12 2008 abschlie end bewerteten Risikomeldungen Fehlerursachen Design Konstruktionsfehler Produktionsfehler Andere produktbezogene Ursache Multifaktorielle Ursachen Nicht produktbezogene Ursache Ursache nicht bekannt nicht feststellbar Wodurch wurde das Problem ausgel st am Anfang liegende erste konkret bestimmbare Ursache in einer m glicherweise vorhandenen Ursachenkette z Erfassung seit 01 01 2006 Stand 03 02 2009 Anzahl der auswertbaren Risikomeldungen 12925 Da es in der Vergangenheit zu Fehlinterpretationen gekommen ist wird der Punkt Gem Hersteller kein Produktfehler nunmehr unter der Rubrik Nicht produktbezogene Ursache als Punkt kein Produktfehler nicht spezifiziert aufgelistet Inhaltliche nderungen sind damit nicht ver
269. ne details of incident nature of device defect FA details of injury to patient carer or healthcare professional FA Action taken includes any action by patient carer or health care professional or by the manufacture or supplier FA Attach file AA Uh your name your address your telephone number your e mail address we have a specific form for reports about breast implants 1 your report about a problem with breast implants y n Ae A om kind of device of device Name of manufacturer Device serial number Name of where you got device address if known Telephone if known Name of person if known Can we contact them y n Have you contacted the manufacturer Where did you get the device from NHS NHS hospital Nurse Pharmacy NHS NHS clinic Private hospital Shop GP surgery Private clinic
270. nt G 2 96 0L GE ke Ho eise 21 Eco 5 0 21 007 SV P S FLORES a9 tech 0 8 st 9 s eel gt 4 0 8 E ALALU S AV CRESS KO 219 BC 299 2 Eco 5 gt BRE OM ee I 7 2109 Q2 23 96 8 se 959 371 49 MEARNS 42 5 69 30 H XR NEALE S BS CRE ear ECKE ar Z Bye Alb ALO H E Plac B oe Be Aly owe GA THEMES ARKEN LAIR v ALIR OBI CERO 8 SZ c a2 He Bb owe AO CIS A SE Gi EE 9 x0 FR ATIY lt S Mg UHREJA Scott TANDU S KO HERE E B SR AG G E AY or o s BOR E MESE ER SEE OG ADAH C sU B E T BOR SR 21 AO t E CERT ATL YOO ET 56 GEIER gt 9 H ALALU gt BE KO THE CAS TANDU S Bese EA C22 GZ N ODEO MND B E21 q 3 AG GE EH ik amp p E 5 SP IR ali ME SE EET Ape Sox n e eu e HY DICE A CO 0 GAD BER E BB s A ED Co I AFRE s
271. of Data roplugzp Cates D Deviae for Ewalus lan De not reng fo PODAJ Retumed to Manufacturer on 11 Coinm nt Medical Produgt and Therapy Date Exucude meztment cf eventi Other Relevant History Including Preexicting Medioal Conditions e alegis nace nregnancy HE dyzfunct an exc INITIAL REPORTER 1 Hama amd Address d nial Reporter Algo 3 Report bo ves unt Submission of a report does not constitute an admission that medical personnel user facility importer distributor manufacturer or product caused or contributed to the event 2 Health Predeccional IS Gcoupation D se EK d EMDR 3 3 8 3 3 9 3 3 10 3 3 8 MDR Database Search Microsoft Internet Explorer F E A BACANA YI
272. omeldungen 12925 Ca 502 Bundesinstitut f r Arzneimittel und Medizinprodukte ae P Vu 1 145 Bi 3 3 31 3 3 32 3 3 33 3 3 34 Anzahl der auswertbaren Risikomeldungen 12954 Stand 04 03 2009 Bundesinstitut fiir Arzneimittel und Medizinprodukte 1 2 Funktionsausfalle und Fehlfunktionen 3 3 31 Statistische Auswertung der im Zeitraum 01 01 2005 bis 31 12 2008 abschlie amp end bewerteten Risikomeldungen Fehlerarten Funktionsausfalle und Fehlfunktionen Ausbleibende Alarmierung Elektrische Fehler UbermaRige Temperaturen und Z ndung brennbarer Gemische Softwareprobleme eigener Art Mechanische Probleme Potentielle Unsterilit t Kontami
273. re worker use this linkto report a medical device related adverse incident online Patients and other members of the public If you are a patient or other member ofthe public including those caring for relatives or friends use this link to report a medical device related adverse incident online Medical device manufacturers If you are a medical device manufacturer authorised representative supplier or distributor use this linkto register and to log in to MORE the Manufacturers Online Reporting Environment 123 Printer friendly version new window Featured publications tj MDA 2009 001 All medical devices 617Kb tj DB 2009 01 Reporting adverse incidents and disseminating MDAs 1210Kb t DB 2009 02 Adverse incident reports 2008 1710Kb Help viewing PDFs Help viewing PDF files Download Acrobat Reader for free Adobe text conversion tools Jump to main content Incident Reporting Home Contact us Back to MHRA T Incident Reporting Home User Reporting About the reporter amp the device There a small number of fields marked with an asterisk These fields must be completed before submitting the form Y ou must select the Type of Device before moving to the second part of the form About the reporter amp the device Device amp Incident details Submit Form Reporters name Position Occupation Reporting
274. rting Home User Reporting Back to MHRA General Report Form all devices There small number of fields marked with an asterisk These fields must be completed before submitting the form About the reporter amp the device Device amp Incident details Submit Form of device Model Manufacturer name Manufacturer phone number Catalogue number Serial number Lot or batch number Date of manufacture Day Month Expiry date Day Month Quantity defective Enter number not text Current location of device Has the manufacturer supplier been contacted Q Yes Is the device CE Marked O Yes O Don t Know Date of incident Has the manufacturer supplier been contacted Is the device CE Marked Yes No Don t Know I Date of incident Day Month Type of injury B O Death Serious Revision Distress C Minor C None Details of incident nature of device defect Details of injury Oo patient carer or healthcare professional Action taken includes any action by patient carer or healthcare professional or by the manufacturer or supplier Attach File Attach file File Name amp Comment Transfer of devices to MHRA Do notsend medical devices to MHRA unless you have been specifically requested to do so Go Back Submit 125 D
275. ty problems This section provides access to information on how to report suspected safety problems with medicines medical devices blood and blood components Medicines Devices Report a suspected adverse reaction or defect Report Report an adverse adverse incident event or reaction The 2005 UK Blood Safety amp Quality Regulations require that serious adverse events and serious adverse reactions related to blaod and blood components are reported to the MHRA the UK Competent Authority for blood safety The MHRA collects information from both health professionals and patients on suspected adverse drug reactions and suspected defects in medicinal products Any adverse incident involving a medical device or its instructions for use should be reported to the MHRA especially if it led to or could have led to death life threatening illness or injury Links info mhra gsi gov uk Freedom of information Report a suspected safety problem E mail alerting service MHRA Portal To contact us about this website use our feedback form Ze About us How we regulate In Reporting safety problems Medicines Devices Medical device adverse incident reporting forms Blood dr Ge wW Dg Printer friendly version new window Help viewing PDFs Help viewing PDF files Download Acrobat Reader for free Adobe text conversion tools Page last modified 07 October 2005
276. uelle der Meldungen Verantwortliche nach 5 MPG oder deren Vertriebsorganisationen Professionelle Anwender Betreiber auch Kommissionen der Heilberufe Sonstige Inverkehrbringer z B Apotheken Sanitatshauser Vigilance Reports EU GHTF Andere Behorden aufer Vigilance Reports Sonstige z B Patienten Laienanwender Rechtsanwalte Durch das BfArM selbst aufgenommene Meldungen Literatur Presse 2000 3000 4000 5000 6000 7000 8000 9000 10000 11000 Stand 04 02 2009 Bundesinstitut f r Arzneimittel und Medizinprodukte 1 2 Verantwortliche nach 5 MPGoder deren VertriebsorganisationenProfessionelle Professionelle Anwender Betreiber 144 3 3 30 Statistische Auswertung der im Zeitraum 01 01 2005 bis 31 12 2008 abschlieRend bewerteten Risikomeldungen Verteilung nach Risikoklassen MP Klasse MP Klasse Messfunktion MP Klasse steril MP Klasse lla Klasse Ilb MP Klasse Ill Aktives Implantat IVD Anhang II Liste A IVD Anhang 11 Liste B IVD zur Eigenanwendung Sonstiges IVD Besonderes Produkt Nicht bekannt 2000 3000 3500 Stand 5 02 2009 Anzahl der auswertbaren Risik
277. y Lx CH DAM ASSL EKON EBS Si lt HAHH c O c ZE 8 C MLE E T ld ap JE BS DAM AST CK T RES SE MT VS CEO ERS SE BH CTI lt Z 362 96 SE SE BE 5 7 46 tc AOR YT HDAC DIE DvVIC TEE EE a E gi 12 905 i52 2 89 10 IAF Hos ALY LLL BOSE S EE e E Xs CX oca o BUE C mH 968 Ie se FRM sv SH 96909 C xad ROC Alt OU Fe 5 E co Qe 2L C Hho He A SLIGO BC xe CH CI Ede co 5 c 240 DHS 966 II 3 691 2 24 71452106 9 2 9619 sC e EYE EXE 5 EUH d bes AZPO CY 901789 sE HG EOS e vie Ae EK Se HG EY BEER 96 SL 4A 24A 2 AE S 8 ear CO HE OF 9 0 s VEAL FEM s E 4 CLE TERI 06 6 aZ R Hilt OOK 1 00 3L e She BE ico C BC 2 2 2432 2I BRE VISIO BIOL E TEM BM OM 96 9 se TS ELE C SS ED 5 XU HETH 212 19 _ EE I RZA CH ELR 901798 3 15 SOS Y LALLA LEON LS EL MYTH BY Tk BY Cores NA R gt ERR UTS xax oss E d

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