BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE THERMACHOICE III

    MDR report key: 2890514 · Received December 21, 2012

    Report

    Report Number
    2890514
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 19, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PRODUCT DID NOT REGISTER PRESSURE ON A FULL BALLOON. WHEN MANUAL PRESSURE WAS PLACED ON THE BALLOON BY THE GYN SURGEON,(OUTSIDE OF THE PATIENT) NO REGISTERED CHANGE ON THERMACHOICE MACHINE. NEW DISPOSABLE THERMACHOICE OBTAINED, AND NO OTHER CHANGES MADE TO MACHINE, AND PRODUCT WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE THERMACHOICE III DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON, INC. * EJMG16

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NONE KNOWN