BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-TOUCH HITE

    MDR report key: 899872 · Received November 3, 2004

    Report

    Report Number
    1019632-2004-00009
    Event Type
    Malfunction
    Date Received
    November 3, 2004
    Report Date
    November 3, 2004
    Manufacturer
    ANSELL SHAH ALAM SDN BHD
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RIGHT INDEX FINGER OF RESIDENTS OUTER GLOVE WAS MISSING. THEY WERE UNSURE IF THE GLOVE WAS LIKE THAT WHEN DONNED OR IF THE FINGER TIP CAME OFF DURING PROCEDURE. THE RESIDENT DOUBLE GLOVED MAKING IT HARD TO DETERMINE IF THE GLOVE WAS ORIGINALLY LIKE THAT, BUT THERE WAS NO FINGERTIP FOUND. THEY EVEN RE-OPENED THE INCISION AND CHECKED IN THE PATIENT CAVITY WHERE PROCEDURE TOOK PLACE AND FOUND NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-TOUCH HITE SURGICAL GLOVE LYY ANSELL SHAH ALAM SDN BHD * 0406253521

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention