BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOVER, EXAMINING, LG, M, & SM.

    MDR report key: 99377 · Received June 20, 1997

    Report

    Report Number
    MW1011537
    Event Type
    Malfunction
    Date Received
    June 20, 1997
    Report Date
    May 21, 1997
    Manufacturer
    SPECTRUM LABORATORIES, INC.
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHEN DONNING THESE GLOVES, IT IS FOUND THAT THERE ARE SMALL HOLES, SLITS, AND WEAK SPOTS IN THEM. THESE DISCREPANCIES CAN BE HARMFUL TO BOTH THE PT AND HEALTHCARE PROVIDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOVER, EXAMINING, LG, M, & SM. GLOVES, EXAMINING. LYY SPECTRUM LABORATORIES, INC. * 11642096,22122096,27022096

    Patients

    Seq Age Sex Outcome Treatment
    1 *