BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3231176 · Received July 5, 2013

    Report

    Report Number
    3231176
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 5, 2013
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS INSERTED INTO THE UTERUS TO BEGIN THERAPY. RED ARRAY POSITION LIGHT WOULD NOT GO OFF. THE DEVICE WAS REMOVED INTACT. ANOTHER DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. NO PATIENT HARM WAS NOTED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ABLATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308277 NOVASURE DEVICE, THERMAL ABLATION MNB HOLOGIC, INC. * 13B25RH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR