BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO TOUCH NITRILE

    MDR report key: 1029603 · Received April 11, 2008

    Report

    Report Number
    1019632-2008-00003
    Event Type
    Other
    Date Received
    April 11, 2008
    Report Date
    April 10, 2008
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN. BHD.
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO NURSES HAD AN IMMEDIATE REACTION AFTER WEARING GLOVES FOR 5-15 MINUTES. IN ONE CASE, THE NURSE HAD THE GLOVES ON FOR APPROX 5 MINUTES WHEN SHE BEGAN TO EXPERIENCE ITCHING ON HER HANDS, WRISTS, THROAT AND MOUTH. SHE PROMPTLY REMOVED THE GLOVES AND WAS NOTED TO HAVE A DEFINITE DEMARCATION OF REDNESS ON HER WRIST WHERE THE GLOVE ENDED. SHE WAS GIVEN BENADRYL, OBSERVED AND SENT HOME AND REFERRED TO MEDICAL FACILITY IF SX DID NOT IMPROVE. THE OTHER NURSE EXPERIENCED ITCHING AND BURNING OF HER HANDS AND WRIST WITHIN 15 MINUTES OF DONNING THE GLOVES. SHE DID NOT HAVE THE SYSTEMIC SX THAT THE FIRST NURSE EXPERIENCED. NO MEDICATION WAS GIVEN AND EARLY RELEASE FROM WORK WAS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO TOUCH NITRILE EXAMINATION GLOVES LZA PERUSAHAAN GETAH ASAS SDN. BHD. 071101622EP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other