BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 23128869 · Received September 23, 2025

    Report

    Report Number
    1924066-2025-00078
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    July 25, 2025
    Report Date
    September 18, 2025
    Manufacturer
    ALLIED MEDICAL LLC.
    Product Code
    HFX
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOT BEEN ABLE TO FURTHER INVESTIGATE THE CAUSE OF THE MALFUNCTION BECAUSE THE DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    CUSTOMER IS REPORTING THAT THE CLAMP GOT STUCK ON AN INFANT DURING A CIRCUMCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541056 GOMCO 500S CIRC CLAMP, EXSMALL HFX ALLIED MEDICAL LLC. 02-00-0500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown