BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXAL NITRILE

    MDR report key: 6175521 · Received December 15, 2016

    Report

    Report Number
    6175521
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 26, 2016
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE HAVE BEEN NUMEROUS OCCASIONS WHERE THE EXAMS GLOVES USED (FLEXAL NITRILE) HAVE BEEN BREAKING DURING THEIR CLEANING OF THE OPERATING ROOMS POST SURGICAL. SINCE THE TECHNICIANS ARE CLEANING THE ROOMS AND MOVING EQUIPMENT, THE WORKERS ARE EXPOSED TO BLOOD AND OTHER FLUIDS IN THE EVENT THE GLOVE TEARS WHILE PERFORMING THIS TASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829746 FLEXAL NITRILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE LZA CARDINAL HEALTH 200, LLC 88TN04L 5D16H070

    Patients

    Seq Age Sex Outcome Treatment
    1