BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 22898985 · Received August 26, 2025

    Report

    Report Number
    1924066-2025-00066
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 20, 2025
    Manufacturer
    ALLIED MEDICAL LLC.
    Product Code
    HFX
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICES WERE RETURNED FOR INVESTIGATION. INITIAL FINDINGS INDICATE INADEQUATE PLATING ADHESION IN CERTAIN LOTS. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED TO FURTHER EVALUATE THE ROOT CAUSE AND TO IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    CUSTOMER IS REPORTING FINISH IS COMING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866657 GOMCO 500 CIRC CLAMP,NEWBORN, HFX ALLIED MEDICAL LLC. 02-01-0500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown