Field Safety Corrective Action Report Form

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1. Administrative information

To which NCA(s) is this report being sent?

Type of reportInitial report

Date of this report

Reference number assigned by the manufacturer

Incidence reference number assigned by NCA

Name of the co-ordinating national competent authority (if applicable)

2. Information on submitter of the report

Status of submitterManufacturer
Authorised Representative within EEA, Switzerland and Turkey
Others

Identify the role:

3. Manufacturer information

Name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

4. Authorised Representative information

Name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

5. National contact point information

National contact point name

Contact name

Address

City

Postcode

Phone

Fax

E-mail

Country

6. Medical device information

Class

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 self-testing
IVD General

Nomenclature system (preferable GMDN)GMDN
UMDNS (ECRI)
EDMS

Nomenclature code

Nomenclature text

Commercial name/brand name/make

Model number

Catalogue number

Serial number(s)

Lot / batch number(s)

Device Manufacturing date

Expiry date

Software version number (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

Progress of FSCA, including reconciliation data (Mandatory for a Final FSCA)

Attachments

Field Safety Notice (FSN) in English

FSN in national language

Others

Please specify:

FSN StatusDraft
Final

Time schedule for the implementation of the different actions

These countries within the EEA and Switzerland and Turkey are affected by this FSCA