BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 2153626 · Received June 29, 2011

    Report

    Report Number
    2153626
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS CONTINUALLY ALARMING WITH CONTINUOUS SHORT BEEPS DURING THE PRIMING PHASE. THE DEVICE WAS REPLACED WITHT THE SAME MANUFACTURER AND MODEL, RESULTING IN COMPLETED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE NOVASURE ENDOMETRIAL ABALATION DEVICE MNB HOLOGIC * 11A25RC

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR