BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCHOICE III

    MDR report key: 1891769 · Received October 22, 2010

    Report

    Report Number
    1891769
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 22, 2010
    Manufacturer
    GYNECARE WORLDWIDE DIVISION OF ETHICON INC
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    DURING THE TESTING STAGE OF THE EQUIPMENT, THERE WAS A LEAKAGE OF D5W SOLUTION FROM THE BALLOON OF THE GYNECARE THERMACHOICE III. NURSE IN CHARGE NOTIFIED. A NEW THERMACHOICE III UTERINE BALLOON THERMAL ABLATION SET WAS OPENED FOR USE FOR THE PROCEDURE. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCHOICE III UTERINE BALLOON THERMAL ABLATION SET MKN GYNECARE WORLDWIDE DIVISION OF ETHICON INC * CHMG12

    Patients

    Seq Age Sex Outcome Treatment
    1 *