Medical Device Nonconformance Report Form
1. General Information
Report No.
Date
Reported By
2. Device Information
Device Name
Model/Type
Serial/Lot No.
3. Nonconformance Details
Description of Nonconformance
Date Detected
How was it Detected?
Location of Occurrence
4. Immediate Action Taken
Immediate Action
Responsible Person
Date
5. Investigation & Root Cause
Investigation Details
Root Cause
6. Corrective & Preventive Action
Corrective Action
Preventive Action
Verified By
Verification Date
Closure (Comments/Remarks)