BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 22636796 · Received July 28, 2025

    Report

    Report Number
    1924066-2025-00055
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ALLIED MEDICAL LLC.
    Product Code
    HFX
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, WE HAVE NOT RECEIVED ANY SUPPORTING SAMPLES OR PHOTOGRAPHIC EVIDENCE; THEREFORE, WE ARE UNABLE TO SUBSTANTIATE THE REPORTED COMPLAINTS.

    Description of Event or Problem · 0

    LABOR AND DELIVERY HAS FLAGGED A SERIOUS ISSUE WITH A GOMCO CLAMP, CITING THAT THE BELL EDGES ARE EXCESSIVELY SHARP AND RESULTED IN A PATIENT LACERATION DURING USE. THIS RAISES IMMEDIATE SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839805 GOMCO 500S CIRC CLAMP 1.1 CM HFX ALLIED MEDICAL LLC. 02-00-0500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown