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    Complaint Form ABC

    Uploaded by

    Bernie Walsh
    This document is a customer complaint form used by ABC Inc. to document any complaints received about their medical devices. It collects information about the complainant, the device in question, the nature of the complaint, an investigation of the complaint, conclusions reached, corrective actions taken, and final resolution. The form has spaces to document the device, lot and model numbers, details of the complaint, attachments provided, assignments for investigation and response, evaluation and disposition decisions, investigation results and conclusions, actions taken with the customer and any recalls or regulatory reporting required.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd

    Complaint Form ABC

    Uploaded by

    Bernie Walsh
    38 views5 pages
    This document is a customer complaint form used by ABC Inc. to document any complaints received about their medical devices. It collects information about the complainant, the device in question, the nature of the complaint, an investigation of the complaint, conclusions reached, corrective actions taken, and final resolution. The form has spaces to document the device, lot and model numbers, details of the complaint, attachments provided, assignments for investigation and response, evaluation and disposition decisions, investigation results and conclusions, actions taken with the customer and any recalls or regulatory reporting required.

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    © Attribution Non-Commercial (BY-NC)

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    This document is a customer complaint form used by ABC Inc. to document any complaints received about their medical devices. It collects information about the complainant, the device in question, the nature of the complaint, an investigation of the complaint, conclusions reached, corrective actions taken, and final resolution. The form has spaces to document the device, lot and model numbers, details of the complaint, attachments provided, assignments for investigation and response, evaluation and disposition decisions, investigation results and conclusions, actions taken with the customer and any recalls or regulatory reporting required.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    38 views5 pages

    Complaint Form ABC

    Uploaded by

    Bernie Walsh
    This document is a customer complaint form used by ABC Inc. to document any complaints received about their medical devices. It collects information about the complainant, the device in question, the nature of the complaint, an investigation of the complaint, conclusions reached, corrective actions taken, and final resolution. The form has spaces to document the device, lot and model numbers, details of the complaint, attachments provided, assignments for investigation and response, evaluation and disposition decisions, investigation results and conclusions, actions taken with the customer and any recalls or regulatory reporting required.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 5

    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 _________________

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