BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFENSE POWDERFREE NITRILE EXAM GLOVES

    MDR report key: 415343 · Received September 9, 2002

    Report

    Report Number
    MW1026081
    Event Type
    Malfunction
    Date Received
    September 9, 2002
    Date of Event
    September 4, 2002
    Report Date
    September 9, 2002
    Manufacturer
    IMS INC.
    Product Code
    LYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE GLOVES WERE PENETRABLE. NURSES WERE INVOLVED IN A CODE SITUATION AND AFTERWARDS BLOOD WAS ON THEIR PALMS. BLUE DYE WAS PLACED ON GLOVES TO TEST THEM AND IT CAME THROUGH. NURSES WERE TESTED FOR HEPATITIS AND HIV. HOSP AND ITS RELATED FACILITIES ALL USE THESE GOVES. THEY ARE ALL ON HOLD PENDING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFENSE POWDERFREE NITRILE EXAM GLOVES EXAM GLOVE LYZ IMS INC. NA 2075-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA