BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE III GYNECARE

    MDR report key: 2170624 · Received July 18, 2011

    Report

    Report Number
    MW5021376
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ETHICON
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON HAS A HOLE, LEAKING FLUIDS NOTICED IT WHILE FILLING UP THE BALLOON. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE III GYNECARE THERMAL CHOICE BALLOON KIT MKN ETHICON CLMG10

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR