BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE THERMACHOICE III

    MDR report key: 3922637 · Received June 24, 2014

    Report

    Report Number
    3922637
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    April 10, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON INSTILLATION OF FLUID BY PHYSICIAN, THE RN OBSERVED LEAKAGE OF THE UTERINE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367680 GYNECARE THERMACHOICE III CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. * GAMG13

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR