BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 23328893 · Received October 17, 2025

    Report

    Report Number
    1924066-2025-00080
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 17, 2025
    Manufacturer
    ALLIED MEDICAL LLC.
    Product Code
    HFX
    UDI-DI
    00026072002308
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES RETURNED. CANNOT DETERMINE THE VALIDITY OF THE COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER REMOVED THE MANUFACTURER DATE STICKERS TO STERILIZE THE CLAMP PRIOR TO USE AND THEY SAID THE FINISH CAME OFF WITH THE STICKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765875 GOMCO 500S CIRC CLAMP, NEWBORN 1.3 HFX ALLIED MEDICAL LLC. 02-01-0500 20250402 00026072002308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown