ABC Inc.

Title:

Document Title: ABC Customer

Complaint Form

Quality System Form

Form No.: 4.14-2.3

Rev. A
Page
1 of 5

Domestic (USA) _________ or International (EU) _______ (check one or both)

SEQUENTIAL COMPLAINT No. __________________________
Device Name __________________________________________
Model Number _____________________________
Catalog Number ___________________________
Lot Number _______________________________
Distributor/EndUser______________________________________________________________
____________________________________________________________________________
Name of Complainant______________________________ Phone No._____________________
Complainant Address
_____________________________________________________________________________
Complaint Received by
_____________________________________________________________________________
Title _____________________________________
Date Received ____________________________
Date Processed____________________________
By: Visit Phone Letter Sales RGA Other
_________________________________________
COMPLAINT ABOUT (Check All That Apply)
Sterility
_____________________________________________________________________________
_____________________________________________________________________________
Contamination ________________ Type and Location_______________________________
Defect/Type and location
_____________________________________________________________________________
Packaging
_____________________________________________________________________________
_____________________________________________________________________________
Labeling , including Instructions for Use
_____________________________________________________________________________

ABC Inc.
Title:

Document Title: ABC Customer

Complaint Form

Quality System Form

Form No.: 4.14-2.3

Rev. A
Page
2 of 5

_____________________________________________________________________________
Patient Death
_____________________________________________________________________________
_____________________________________________________________________________
Patient Injury
_____________________________________________________________________________
_____________________________________________________________________________
Product Malfunction
_____________________________________________________________________________
Other (specify)
_____________________________________________________________________________
_____________________________________________________________________________
Comments/Description of Event
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
ATTACHMENTS Implicated Sample Associated Sample Letter (Check One)
Received By ABC QA Mgr and/or Authorized Representative
____________________________________Date _____________________________________
Assigned To __________________________________Response Due Date________________
Instructions
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Initial Evaluation Summary and Disposition:
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________

ABC Inc.
Title:

Document Title: ABC Customer

Complaint Form

Quality System Form

Form No.: 4.14-2.3

Rev. A
Page
3 of 5

Complaint ___________ Medical __________, Non-Medical _________, Undetermined ______

Not a Complaint ________________________

Action/Justification
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________

Complaint Investigation Distribution: Quality Control Engineering Production QA

Sales OEM Manufacturer or Supplier (Check All That Apply)

COMPLAINT INVESTIGATION
Date(s) Investigation(s) were performed
_____________________________________________________________________________
Investigation Results
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Copy of investigation attached_____________ Report # ___________

CONCLUSIONS
Device Defective Device Failed to Meet Specifications Improper Use
Shipping Damage Repair Request
Other(specify)
_____________________________________________________________________________

ABC Inc.
Title:

Document Title: ABC Customer

Complaint Form

Quality System Form

Form No.: 4.14-2.3

Rev. A
Page
4 of 5

_____________________________________________________________________________
_____________________________________________________________________________
If no Investigation was conducted documented justification
_____________________________________________________________________________
_____________________________________________________________________________
___________________________________________________________________________

ACTION/REPLY TO COMPLAINANT

None. Reason for no action

__________________________________________________________________

Action
_______________________________________________________________________
_______________________________________________________________________

Recall. FDA phoned on - Date ______________ Spoke to ___________________________

Complaint Committee Informed on - Date ___________________
MDR Filed on - Date __________________
Vigilance Reported on- Date______________________

Referred to _________________________________ for Further Investigation or Correction

Replaced Repaired Credited Letter Sent Sales Follow Up

Reason for No Reply

__________________________________________________________________________
Corrective and Preventive Action (Summary)
_____________________________________________________________________________
_____________________________________________________________________________

ABC Inc.
Title:

Document Title: ABC Customer

Complaint Form

Quality System Form

Form No.: 4.14-2.3

Rev. A
Page
5 of 5

_____________________________________________________________________________
_____________________________________________________________________________
CAPA Report # (If applicable) ______________________
Follow-up Summary (and date if applicable)
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________

NOTES:
FINAL DISPOSITION
___________________________________________________________________________
Reviewed by: Quality Assurance ___________________________ Date _________________If requested: Engineering _________________________________ Date _________________
Production _____________________________________________Date _________________