BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 21814245 · Received April 10, 2025

    Report

    Report Number
    1924066-2025-00051
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ALLIED MEDICAL LLC
    Product Code
    HFX
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT HAS NOT BEEN RETURNED AND THE PICTURES WERE NOT PROVIDED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THEY HAVE GOMCO CLAMPS THAT THE PLATING IS COMING OFF. THIS IS AN ONGOING MATTER THAT JOHN DIAMOND WITH DIV15 INSTRUMENTS IS AWARE OF. WE ARE TO REPLACE THEM WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471676 GOMCO 500 CIRC CLAMP 1.3 HFX ALLIED MEDICAL LLC 02-01-0500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other