BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1639108 · Received March 19, 2010

    Report

    Report Number
    MW5015245
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 19, 2010
    Manufacturer
    CQ LABS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE DILATATION AND CURETTAGE AND ENDOMETRIAL ABLATION PROCEDURE, TRUMPET VALVE WAS NOT WORKING PROPERLY. THE SURGEON ATTEMPTED TO HEAT THE WATER UP, BUT IT DECLARED THAT THERE WAS A HEATING ERROR BEFORE IT COULD EVEN REACH THE 87 DEGREES CELSIUS. AT THAT TIME, WE DECIDED TO GO AHEAD AND USE THE HYDRO THERMOABLATION EQUIPMENT PANNICULECTOMY AND ABDOMINAL PLASTIC SURGERY REMOVING EXCESS SKIN IN PANNICULUS IN 2007, HYPOTHYROIDISM. HERNIA REPAIR, CHOLECYSTECTOMY, CAESAREAN SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE ABLATION GEI CQ LABS TC003 CBMG02

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability