Manufacturer’s Incident Report Form


1. Administrative information

2. Information on submitter of the report

3. Manufacturer information
4. Authorised Representative information
5. Submitter´s information (if different from section 3 or 4)
6. Medical device information

7. Incident information

8. Patient information

9. Healthcare facility information
10. Manufacturer’s preliminary comments
11. Results of manufacturer's final investigation

NOTE: In the case of a FSCA the submitter needs to fill in the Report Form Field Safety Corrective Action

For Final Report only:

The medical device has been distributed to the following countries

Within EEA, Switzerland and Turkey