BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXAMINATION GLOVE

    MDR report key: 33900 · Received July 3, 1996

    Report

    Report Number
    MW1009434
    Event Type
    Malfunction
    Date Received
    July 3, 1996
    Report Date
    July 2, 1996
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FMC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE CONTAMINATION BECAUSE THE GLOVE IS DETERIORATING AND THERE IS NO PROTECTIVE BARRIER. THE GLOVES ARE FULL OF HOLES AND TEAR EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXAMINATION GLOVE EXAMINATION GLOVE FMC PHARMASEAL DIV. BAXTER HEALTHCARE CORP. P8876, P8877, P8878

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO