BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNITRILE PF BLUE

    MDR report key: 874397 · Received June 15, 2007

    Report

    Report Number
    1451040-2007-00002
    Event Type
    Malfunction
    Date Received
    June 15, 2007
    Date of Event
    May 14, 2007
    Report Date
    June 15, 2007
    Manufacturer
    TOP GLOVE SDN. BHD.
    Product Code
    FMC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "EVENT DESC: LAB PERSONNEL HAVE BEEN EXPERIENCING PROBLEMS WITH THE QUALITY OF THE BLUE NITRILE GLOVES BEING USED. THE GLOVES RIP VERY EASILY AND STICK TOGETHER IN CLUMPS IN THE BOXES. THE SIZING AS WELL AS THICKNESS OF THE GLOVES HAVE BEEN NOTED TO BE VERY INCONSISTENT BOX TO BOX. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNITRILE PF BLUE GLOVES, EXAM NITRILE FMC TOP GLOVE SDN. BHD. UNK MTG01-10321

    Patients

    Seq Age Sex Outcome Treatment
    1 * OTHER THERAPIES IN USE ON THE PT: NA| OTHER DEVICES IN USE ON PT: NONE