Medical Device Adverse Event Report
1. Reporter Details
Name
Contact Information
Institution/Organization
2. Patient Information
Patient Age
Patient Gender
3. Device Information
Device Name
Model Number
Serial/Lot Number
Manufacturer
Date of Manufacture
Date of Implantation (if applicable)
4. Event Information
Event Date
Description of Event
Consequence/Outcome
5. Actions & Follow-up
Immediate Actions Taken
Device Disposition (Returned, Retained, etc.)
Other Relevant Information