BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRENE ULTRA

    MDR report key: 1586395 · Received January 19, 2010

    Report

    Report Number
    1586395
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 19, 2010
    Manufacturer
    ANSELL DERMA
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GREEN STERILE SURGICAL GLOVES DISCOLORED WITH BLACK SPLOTCHES.WERE NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRENE ULTRA GLOVES KGO ANSELL DERMA * 0810003405

    Patients

    Seq Age Sex Outcome Treatment
    1 *