BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLOVE EXAM NS PF NITRILE ESTEEM SZ MD

    MDR report key: 1616822 · Received February 5, 2010

    Report

    Report Number
    1423507-2010-00008
    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
    CA, 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 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 CAUSED BY CONTACT DERMATITIS AND MAY NOT BE ALLERGIC IN NATURE AT ALL. WE WILL CONTINUE TO MONITOR TRENDS.

    Description of Event or Problem · 1

    FLOOR NURSE REPORTED THAT THE BACK OF HER HANDS BECAME DRY AND IRRITATED/RED, AND SHE FELT BURNING. SHE REPORTED THE INCIDENT TO EMPLOYEE HEALTH, SHE USED EUCERIN CREAM, AND SHE STOPPED WEARING THE GLOVE. THE NURSE WAS SEEN BY A PRIMARY CARE PHYSICIAN ON (B)(6)2010, GIVEN 1% CORTISONE GEL, AND WAS OFF WORK UNTIL (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOVE EXAM NS PF NITRILE ESTEEM SZ MD NITRILE POWDER-FREE EXAM GLOVE LZA CARDINAL HEALTH NOT LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other