【文章內(nèi)容簡介】 evices for selftesting□IVD GeneralNomenclature system (preferable GMDN)Nomenclature codeNomenclature textCommercial name/ brand name / makeModel numberCatalogue numberSerial number(s) (if applicable)Lot/batch number(s) (if applicable)Software version number (if applicable)Device Manufacturing dateExpiry dateImplant date (for implants only)Explant date (for implants only)Duration of implantation (to be filled is the exact implant or explant dates are unknown)Accessories/ associated device (if applicable)Notified Body (NB) IDnumber7. Incident informationUser facility report reference number, if applicableManufacturers awareness dateDate the incident occurredIncident description narrativeNumber of patients involved (if known)Number of medical devices involved (if known)Medical device current location/disposition (if known)Operator of the medical device at the time of incident (select one)□health care professional patient□other□patientUsage of the medical device (select from list below)□initial use reuse of a single use medical device□reuse of a reusable medical device reserviced/refurbished□other (please specify)□problem noted prior use□reuse of a single use medical device□reserviced/refurbished8. Patient informationPatient outeRemedial action taken by the healthcare facility relevant to the care of the patientAge of the patient at the time of incident, if applicableGender, if applicable□Female□MaleWeight in kilograms, if applicable9. Healthcare facility informationName of the health care facilityContact person within the facilityAddressPostcodeCityPhoneFaxEmailCountry10. Manufacturer’s preliminary ments (Initial/Followup report)Manufacturer’s preliminary analysisInitial corrective actions/preventive actions implemented by the manufacturerExpected date of next report11. Results of manufacturers final investigation (Final report)The manufacturer’s device analysis resultsRemedial action/corrective action/preventive action / Field Safety Corrective ActionNOTE: In the case of a FSCA the submitter needs to fill in the form of Annex 4Time schedule for the implementation of the identified actionsFinal ments from the manufacturerFurther investigationsIs the manufacturer aware of similar incidents with this type of medical device with a similar root cause?□Yes □NoNumber of similar incidents.If yes, state in which countries and the report reference numbers of the incidents.For Final Report only: The medical device has been distributed to the following countries:Within EEA, Switzerland and Turkey:□AT □BE □BG □CH □CY □CZ □DE □DK □EE □ES□FI □FR □GB □GR □HU □IE □IS □IT □LI □LT□LU □LV □MT □NL □NO □PL □PT □RO □SE □SI□SK □TRCandidate Countries:□HR□All EEA, Candidate Countries, Switzerland and TurkeyOthers:12. CommentsSubmission of this report does not, in itself, represent a conclusion by the manufacturer and / orauthorized representative or the National Competent Authority that the content of this report isplete or accurate, that the medical device(s) listed failed in any manner and/or that the medicaldevice(s) caused or contributed to the alleged death or deterioration in the state of the health of anyperson.I affirm that the information given above is correct to the best of my knowledge.………………………………………………………Name City date附錄四：Manufacturer’s Field Safety Corrective Action ReportMedical Devices Vigilance System(MEDDEV )1. Administrative informationTo which NCA(s) is this report being sent?Type of report□Initial report□Follow up report□Final reportDate of this reportReference number assigned by the manufacturerFSCA reference number assigned by NCAIncidence reference number assigned by NCAName of the coordinating national petent authority (if applicable)2. Information on submitter of the reportStatus of submitter□Manufacturer□Authorised representative within EEA, Switzerland and Turkey□Others (identify the role):3 Manufacturer informationNameContact nameAddress PostcodeCityPhoneFaxEmailCountry4 Authorised representative informationNameContact nameAddressPostcodeCityPhoneFaxEmailCountry5 National contact point informationNational contact point nameName of the contact personAddressPostal codeCityPhoneFaxEmailCountry6 Medical device informationClass□AIMD Active implants□MDD Class III□MDD Class IIb□MDD Class IIa□MDD Class I□IVD Annex II List A□IVD Annex II List B□IVD Devices for selftesting□IVD GeneralNomenclature system (preferable GMDN)Nomenclature codeNomenclature textCommercial name/brand name/makeModel numberCatalogue numberSerial number(s)lot/batch number(s)Device Manufacturing dateExpiry dateSoftware version number (if applicable)Accessories/associated device (if applicable)Notified body (NB) ID number7 Description of FSCABackground information and reason for the FSCADescription and justification of the action (corrective/preventive)Advice on actions to be taken by the distributor