BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE THERMACHOICE UTERINE BALLOON THERAPY

    MDR report key: 1781493 · Received July 28, 2010

    Report

    Report Number
    MW5016844
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 28, 2010
    Manufacturer
    GYNECARE
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE RN IN THE OPERATING ROOM WHEN SHE PLUGGED IN THE THERMACHOICE BALLOON, THE MACHINE SHOWED ERROR "MOTOR FAULT". BALLOON WAS REMOVED FROM THE MACHINE AND A NEW ONE WAS OPENED FOR PROCEDURE. NO HARM WAS DONE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE THERMACHOICE UTERINE BALLOON THERAPY THERMACHOICE MKN GYNECARE CGMG05

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR