BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELI ON NITRILE GLOVES

    MDR report key: 2278731 · Received September 29, 2011

    Report

    Report Number
    1019632-2011-00009
    Event Type
    Other
    Date Received
    September 29, 2011
    Report Date
    September 29, 2011
    Manufacturer
    PGA - PERUSAHAAN GETAH ASAS SDN BHD
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCED AN ALLERGIC REACTION AFTER USING THE RELI ON NITRILE GLOVE. THE REACTION INCLUDED FACE SWELLING, AND BURNING/BLISTERING OF RIGHT HAND. CUSTOMER WENT TO EMERGENCY ROOM WHERE SHE RECEIVED SHOTS AND PREDNISONE. CUSTOMER WAS OUT OF WORK FOR SEVEN DAYS. CUSTOMER IS STILL USING PRODUCT FROM THE SAME BOX WITHOUT ANY REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELI ON NITRILE GLOVES NITRILE DISPOSABLE GLOVES LZA PGA - PERUSAHAAN GETAH ASAS SDN BHD 11050194EP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other