BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE II

    MDR report key: 477223 · Received August 1, 2003

    Report

    Report Number
    MW1029224
    Event Type
    Malfunction
    Date Received
    August 1, 2003
    Date of Event
    July 23, 2003
    Report Date
    August 1, 2003
    Manufacturer
    GYNECARE, INC.
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING OR PROCEDURE, MACHINE FAILED X3 WITH ERROR MESSAGE OF "CHANGE BALLOON", AND "CHECK PINS". THE PT NEVER RECEIVED TREATMENT WITH THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE II UTERINE BALLOON THERAPY MACHINE MKN GYNECARE, INC. EAS2000-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other 2. 3 PRODUCTS: PN#05687.| 1. 2 CABLES