BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 22746175 · Received August 7, 2025

    Report

    Report Number
    1924066-2025-00063
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 8, 2025
    Report Date
    August 7, 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

    CUSTOMER HAVING ISSUES WITH BOTH 02-01-0500 AND 02-00-0500 BEING TO SHARP AND ADDING EXCESSIVE BLEEDING REQUIRING STITCH TO NEWBORN CIRCUMCISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220711 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