BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLV PF STRETCHY NITRILE II EXAM SZ LG

    MDR report key: 1616821 · Received February 5, 2010

    Report

    Report Number
    1423507-2010-00007
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 3, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE AND THE LOT NUMBER WERE NOT PROVIDED BY THE CUSTOMER. HISTORICAL TRENDING WAS DONE. THE DEVICE HISTORY RECORD WAS NOT REVIEWED DUE TO THE UNAVAILABILITY OF THE LOT NUMBER. A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE ALLERGIC REACTION TO SOME OF THE ANTI-OXIDANTS AND ACCELERATORS, WHICH MAY BE ADDED DURING THE MANUFACTURING PROCESS. OFTEN, REACTIONS MAY BE CAUSED BY CONTACT DERMATITIS AND MAY NOT BE ALLERGIC IN NATURE AT ALL. WE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    A (B)(4) NURSE DEVELOPED AN ITCHY RASH ON HER HANDS/FINGERS WITH USAGE OF THE GLOVE. SHE SOUGHT MEDICAL CARE, AND USED LIDEX CREAM. THE RASH IS NOW GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLV PF STRETCHY NITRILE II EXAM SZ LG NITRILE POWDER-FREE EXAM GLOVE LZA CARDINAL HEALTH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other