BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXXIM MEDICAL

    MDR report key: 280297 · Received May 24, 2000

    Report

    Report Number
    MW1019033
    Event Type
    Malfunction
    Date Received
    May 24, 2000
    Date of Event
    May 21, 2000
    Report Date
    May 22, 2000
    Manufacturer
    MAXXIM MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAXXIM DISPOSABLE CAUTERY UNIT WAS BEING USED TO RELIEVE A HEMATOMA OF THE RIGHT RING FINGER AND THE CAUTERY TIP BROKE OFF AND BECAME IMBEDDED IN THE PT'S NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXXIM MEDICAL SURGICAL CAUTERY GEI MAXXIM MEDICAL 005-5-301 1299-2

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR