BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-PAK LIGHTLY POWDERED EXAM GLOVES

    MDR report key: 43964 · Received October 21, 1996

    Report

    Report Number
    MW1010120
    Event Type
    Malfunction
    Date Received
    October 21, 1996
    Date of Event
    October 19, 1996
    Manufacturer
    GENERAL MEDICAL MFG CO.
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR HAS USED THIS PRODUCT FOR SEVERAL MONTHS AND EXPERIENCED PERSISTENT POOR GLOVE QUALITY. VERY THIN LATEX IS USED RESULTING IN EASY TEARING. NUMEROUS GLOVES COME OUT OF THE BOX WITH HOLES IN THEM EVEN WITH INCOMPLETE FINGERS. THIS HAS LED TO SKIN EXPOSURE TO BLOOD AND BODY SECRETIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-PAK LIGHTLY POWDERED EXAM GLOVES LATEX GLOVE LYY GENERAL MEDICAL MFG CO. 49-001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other