BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 22898989 · Received August 26, 2025

    Report

    Report Number
    1924066-2025-00072
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 16, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ALLIED MEDICAL LLC.
    Product Code
    HFX
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    THEIR STERILE PROCESSING DEPT AND INFECTION CONTROL STAFF DETERMINED THESE ARE NOT SERVICEABLE ANYMORE DUE TO GOUGES AND SCRATCHES IN THE METAL AND THEY HAVE ONLY BEEN IN USE FOR LESS THAN 7 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866661 GOMCO 500 CIRC CLAMP,NEWBORN, HFX ALLIED MEDICAL LLC. 02-01-0500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown