BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE THERMACHOICE III UTERINE BALLON THERAPY

    MDR report key: 1586371 · Received January 7, 2010

    Report

    Report Number
    1586371
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 7, 2010
    Manufacturer
    GYNECARE WORLDWIDE
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHEN INITIALLY INSTILLING D5W, MACHINE APPEARED NOT TO RECOGNIZE THE CHANGE IN THE BALLOON PRESSURE. DR STATED THE SAME THING HAD HAPPENED PREVIOUSLY THIS WEEK DESPITE TRYING NEW DISPOSABLE UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE THERMACHOICE III UTERINE BALLON THERAPY ABLATION, ENDOMETRIAL MKN GYNECARE WORLDWIDE * BDMG15

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO OTHER THERAPIES