BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE III

    MDR report key: 2150681 · Received June 23, 2011

    Report

    Report Number
    2150681
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ETHICON
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    SURGERY STAFF REPORT THAT THERE WAS A HOLE IN THE BALLOON. IT WOULD NOT STAY UP AT THE 87 DEGREE C NEEDED FOR THE COMPLETE THERAPY. A SECOND DEVICE WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT.======================MANUFACTURER RESPONSE FOR UTERINE BALLOON THERAPY, GYNECARE (PER SITE REPORTER)======================WILL SEND RETURN KIT TO EVALUATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE III UTERINE BALLOON THERAPY MKN ETHICON TC003 CJMG03

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN