BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE THERMACHOICE III

    MDR report key: 1830665 · Received August 31, 2010

    Report

    Report Number
    1830665
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ETHICON
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PRESSURE READING MALFUNCTIONED ON THE GYNECARE THERMACHOICE*III UTERINE BALLOON. THIS BALLOON WAS DISCARDED AND THE SECOND ONE WORKED AND THE ABLATION WAS SUCCESSFULLY COMPLETED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY WITH FLUID CIRCULATION MKN ETHICON REF TC003 BPMG05

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR