BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK

    MDR report key: 1651781 · Received March 26, 2010

    Report

    Report Number
    1651781
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    March 26, 2010
    Report Date
    March 26, 2010
    Manufacturer
    KIMBERLY CLARK
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE NOTED BLOOD ON HER HAND AFTER DEGLOVING AFTER A PATIENT PROCEDURE. THE GLOVE INTEGRITY WAS CHECKED FOR ANY TEARS AND HOLES WITH NONE NOTED. ANOTHER SET OF GLOVES FROM THE SAME BOX WAS TESTED WITH INK TO VERIFY GLOVE INTEGRITY WITH SATURATION BREAK THROUGH EVIDENT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK STERLING NITRILE POWDER FREE EXAM GLOVES - SMALL LZA KIMBERLY CLARK KC300 SC92775LX

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES