MEDDEV 2 12-1 rev. 8 VigilanceANNEX 3 - REPORT FORM FOR MANUF NATIONAL COMPETENT AUTHORITY v.01.13Report FormMedical Devices Vigilance System(MEDDEV 2.12/1 rev 8)1. Administrative informationRecipientStamp box for the CompetentName of National Competent Authority (NCA)Authority (~ 60 x 40 mm)Address of National Competent AuthorityDate of this reportReference number assigned by the manufacturerReference number assigned by NCAType of reportInitial reportFollow-up reportCombined Initial and final reportFinal reportDoes the incident represent a serious public health threat?YesNoClassification of incidentDeathUnanticipated serious deterioration in state of healthAll other reportable incidentsIdentify to what other NCAs this report was also sent2. Information on submitter of the reportStatus of submitterManufacturerAuthorised Representative within EEA, Switzerland and TurkeyOthers: (identify the role) :40MEDDEV 2 12-1 rev. 8 Vigilance3. Manufacturer informationNameContact nameAddressPostcodeCityPhoneFaxE-mailCountry4. Authorised Representative informationNameContact nameAddressPostcodeCityPhoneFaxE-mailCountryContact nameAddressPostcodeCityPhoneFaxE-mailCountry6. Medical device informationClassAIMD Active implantsIVD Annex II List AMDD Class IIIIVD Annex II List BMDD Class IIbIVD Devices for self-testingMDD Class IIaIVD GeneralMDD Class INomenclature system (preferable GMDN)Nomenclature codeNomenclature text41MEDDEV 2 12-1 rev. 8 VigilanceCommercial 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) ID-number7. 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 professionalpatientotherUsage of the medical device (select from list below)initial usereuse of a reusable medical device other (please specify)problem noted prior use reuse of a single use medical device re-serviced/refurbished8. Patient informationPatient outcomeRemedial action taken by the healthcare facility relevant to the care of the patient42MEDDEV 2 12-1 rev. 8 VigilanceAge of the patient at the time of incident, if applicableGender, if applicableFemaleMaleWeight in kilograms, if applicable9. Healthcare facility informationName of the health care facilityContact person within the facilityAddressPostcodeCityPhoneFaxE-mailCountry-up report)Initial corrective actions/preventive actions implemented by the manufacturerExpected date of next report11. Results of manufacturers final investigation (Final report)Remedial 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 comments 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:43MEDDEV 2 12-1 rev. 8 VigilanceWithin EEA, Switzerland and Turkey:ATBEBGCHCYCZDEDKEEESFIFRGBGRHUIEISITLILTLULVMTNLNOPLPTROSESISKTRCandidate Countries:HRAll EEA, Candidate Countries, Switzerland and TurkeyOthers:12. CommentsSubmission of this report does not, in itself, represent a conclusion by the manufacturer and / or authorized representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.I affirm that the information given above is correct to the best of my knowledge.NameCity date44