BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAISMED

    MDR report key: 561211 · Received December 1, 2004

    Report

    Report Number
    MW1033943
    Event Type
    Malfunction
    Date Received
    December 1, 2004
    Date of Event
    November 21, 2004
    Report Date
    December 1, 2004
    Manufacturer
    WAISMED, LTD.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNABLE TO OBTAIN IV ACCESS IN PT WITH SEVERE BLOOD LOSS DUE TO WHAT PROVED TO BE MORTAL TRAUMATIC INJURIES. UNABLE TO REMOVE NEEDLE FROM BONE AFTER FIRING DEVICE. HAD TO RESORT TO SURGICAL "CUT-DOWN" TO ESTABLISH IV ACCESS TO ADMINISTER RESUSCITATIVE FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAISMED BONE INJECTOR GUN -B.I.G.- - PEDIATRIC FMI WAISMED, LTD. * 18

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other