BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLV EXAM TRU-BLU NITRILE PF LG

    MDR report key: 1628705 · Received February 25, 2010

    Report

    Report Number
    1423507-2010-00014
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    January 27, 2010
    Report Date
    February 23, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS UNABLE TO PROVIDE THE SAMPLE OR THE LOT NUMBER, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HISTORICAL TRENDING WAS DONE. A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE ALLERGIC REACTIONS TO SOME OF THE ANTI-OXIDANTS AND ACCELERATORS, WHICH MAY BE ADDED DURING THE MFG PROCESS. A REACTION TO AN ACCELERATOR OR TO THE GLOVE MATERIAL MAY RESULT IN A CONTACT DERMATITIS. PER THE CUSTOMER, THIS NURSE MAY BE ALLERGIC TO NITRILE. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT HE DEVELOPED A FINE RED RASH ON HIS HANDS AFTER WEARING THE GLOVES. HE WENT TO EMPLOYEE HEALTH AND WAS GIVEN ACCENT PLUS 3 CREAM TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLV EXAM TRU-BLU NITRILE PF LG EXAMINATION GLOVE LZA CARDINAL HEALTH NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other