1. Complaint Identification

Complaint ID: Date Complaint Received: Received by (Name & Title):

2. Complainant Information

Name: Address: Phone/Email:

3. Device Information

Device Name: Model Number: UDI/UPC or Control Number: Lot/Batch Number: Date of Manufacture (if known): Date of Use (if applicable):

4. Complaint Details

Nature of Complaint (as described by complainant):

5. FDA MDR Evaluation

Complaint meets MDR criteria? MDR Number (if filed): MDR Event Filed By: Date Filed: Location of MDR File:

6. Investigation Determination

Investigation Required? If No, Reason: Reviewed by: Date:

7. Investigation Record

Investigation Start Date: Investigator(s): Summary of Investigation: If Root Cause Identified, specify: Corrective Actions Taken (if any): Investigation End Date: Results of Investigation:

8. Communication with Complainant

Reply Provided? Date of Reply: Summary of Response:

9. Accessibility Compliance

Final Review and Signature

Reviewed by: Title: Signature: Date: