安全纠正措施报告表.docxVIP

NO. Rev.A Report Form Field Safety Corrective Action Medical Devices Vigilance System (MEDDEV 2.12/1 rev 5) 1 Administrative information Destination Name of National Competent Authority ： Address of National Competent Authority： Date of this report Reference number assigned by the manufacturer Incident reference number and name of the co-ordi nating NCA Competent Authority (if applicable): Identify to what other Competent Authorities this report was also sent 2 Information on submitter of the report Status of submitter □ Manufacturer □Authorised Representative within EEA □Others: (identify the role): 3 Manufacturer information Manufacturer name: Manufacturer’s contact person: Address: Postal code City Phone Fax E-mail Country 4 Authorised Representative information Name of the Authorised Representative: The Authorised Representative’s contact person: Address Postal code City Phone Fax E-mail Country 5 National contact point information National contact point name: Name of the contact person: Address: Postal code City Phone Fax E-mail Country 6 Medical device information Class: □AIMD Active implants □MDD Class III □ IVD Annex II List A □MDD Class IIb □IVD Annex II List B □MDD Class IIa □IVD Devices for self-testing □MDD Class I □IVD General Nomenclature system (preferable GMDN): Nomenclature code: Nomenclature text: Commercial name/ brand name / make Model number Serial number(s) or lot/batch number(s) Software version number (if applicable) Manufacturing date/ Expiry date (if applicable) Accessories/ associated device (if applicable) Notified Body (NB) ID-number 7 Description of FSCA Background information and reason for the FSCA: Description and justification of the action (corrective/preventive) Advice on actions to be taken by the distributor and the user. Attached please fin