BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 20767965 · Received November 24, 2024

    Report

    Report Number
    1924066-2024-00096
    Event Type
    Malfunction
    Date Received
    November 24, 2024
    Date of Event
    April 12, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ALLIED MEDICAL LLC.
    Product Code
    HFX
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEEP SCRATCHES WITH THE BRASS SHOWING THROUGH.

    Description of Event or Problem · 0

    THE END USER LIZ TRAIL0BURNS REPORTED TO OWENS AND MINOR (THE DISTRIBUTOR) THAT THE METAL IS FLAKING OFF WHEN ATTEMPTING TO STERILZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2578303 GOMCO 500 CIRC CLAMP, NEWBORN 1.3 CM HFX ALLIED MEDICAL LLC. 02-01-0500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown