BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAREX SAFE TOUCH GLOVES

    MDR report key: 427931 · Received October 23, 2002

    Report

    Report Number
    427931
    Event Type
    Malfunction
    Date Received
    October 23, 2002
    Date of Event
    October 14, 2002
    Report Date
    October 23, 2002
    Manufacturer
    DYNAREX CORPORATION
    Product Code
    LYZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAFF NURSE WAS DISCONTINUING HEMODIALYSIS CANNULATION NEEDLES AFTER COMPLETED TREATMENT. "P.P.E.S" WERE USED INCLUDING EXAM GLOVES AFTER NEEDLES WERE PULLED AND SITES HELD MANUALLY BY NURSE, BLOOD WAS NOTED INSIDE (NURSES RIGHT INDEX FINGER) GLOVE. SMALL HOLE NOTED IN GLOVE. THIS PARTICULAR PT WAS HEPATITIS C POSITIVE. TWO OTHER NURSES HAD SIMILAR INCIDENTS. ONE WITH BLOOD, ANOTHER WITH WATER AT SINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAREX SAFE TOUCH GLOVES NON STERILE VINYL EXAM GLOVES LYZ DYNAREX CORPORATION SIZE SMALL 14859

    Patients

    Seq Age Sex Outcome Treatment
    1 *