BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOMCO

    MDR report key: 20767959 · Received November 24, 2024

    Report

    Report Number
    1924066-2024-00095
    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 (B)(4) (THE DISTRIBUTOR) THAT THE METAL IS FLAKING OFF WHEN ATTEMPTING TO STERILIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779190 GOMCO 500S CIRC CLAMP, EX SMALL1.1 CM HFX ALLIED MEDICAL LLC. 02-00-0500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown