BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE III GYNECARE UTERINE BALLON THERAPY

    MDR report key: 2463192 · Received February 13, 2012

    Report

    Report Number
    2463192
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    ETHICON
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    BALLON LEAKING FLUID- BALLOON OUT OF PACKAGE HAD LEAK; THIS UNIT TAKEN OFF THE BACK TABLE; NEW DEVICE ADDED TO BACK TABLE AND WORKED JUST FINE; LEAKING BALLOON SAVED TO RETURN TO VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE III GYNECARE UTERINE BALLON THERAPY THERMAL BALLOON ABLATION SILICONE CATHETER WITH FLUID CIRCUL MKN ETHICON * DKMG10

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR