BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE INSTRUMENT BLACK HANDLE NERVE HOOK

    MDR report key: 8837853 · Received July 26, 2019

    Report

    Report Number
    MW5088423
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 17, 2019
    Report Date
    July 24, 2019
    Manufacturer
    LIFE INSTRUMENT CORP
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF NERVE HOOK BROKE ON THE STERILE FIELD. NO INJURIES TO PATIENT. PROCEDURE CONTINUED WITHOUT INCIDENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624395 LIFE INSTRUMENT BLACK HANDLE NERVE HOOK HOOK, SURGICAL, GENERAL AND PLASTIC SURGERY GDG LIFE INSTRUMENT CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR