BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLV EXAM ESTEEM PF STRETCHY NITRILE MD

    MDR report key: 1012366 · Received March 13, 2008

    Report

    Report Number
    1423507-2008-00028
    Event Type
    Other
    Date Received
    March 13, 2008
    Date of Event
    December 1, 2007
    Report Date
    March 12, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT ABLE TO PROVIDE THE SAMPLE OR THE LOT NUMBER. WITHOUT THE LOT NUMBER, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. THERE ARE NO CHANGES IN THE MANUFACTURING PROCESS AND FORMULATION. A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE AN ALLERGIC REACTION TO SOME OF THE ANTI-OXIDANTS AND ACCELERATORS WHICH MAY BE ADDED DURING THE MANUFACTURING PROCESS. SOME REACTIONS MAY BE CAUSED BY CONTACT DERMATITIS AND MAY NOT BE ALLERGIC IN NATURE AT ALL.

    Description of Event or Problem · 1

    PHLEBOTOMIST DEVELOPED WELTS/SORES ON HANDS. SAW A PHYSICIAN AND SAW A DIFFERENT PHYSICIAN. TRIAMCINOLONE WAS PRESCRIBED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLV EXAM ESTEEM PF STRETCHY NITRILE MD NITRILE POWDER FREE EXAM GLOVE FMC CARDINAL HEALTH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other