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2 VitalSleep Mouthpiece - 2 Sleep Masks, 2 Cleaning Brushes
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Complaint Form
Device Complaint Investigation Form
🔧 Device Complaint Investigation Form
Complies with 21 CFR §820.198
1. Complaint Identification
Complaint ID:
Date Complaint Received:
Received by (Name & Title):
Received via:
Phone (oral)
Email
Written Letter
In Person
Other
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):
Device-related?
Used for treatment/diagnosis?
Issue involves:
Labeling
Packaging
Mechanical Failure
Electrical Failure
Fit/Function
Harm or Adverse Event
Other
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:
Device failed to meet specifications?
Similar investigation already performed?
Root Cause Identified?
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
Complaint record accessible at U.S. location
Complaint record available to manufacturing establishment
Final Review and Signature
Reviewed by:
Title:
Signature:
Date:
