BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3766971 · Received April 18, 2014

    Report

    Report Number
    MW5035742
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    HOLOGIC INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOLOGIC INC NOVASURE DEVICE PASSED CAVITY ASSESSMENT/TEST BUT WOULD NOT ACTIVATE TO PROVIDE TREATMENT. A SUBSEQUENT "LIKE" DEVICE WAS OPENED AND UTILIZED WITHOUT ISSUE. (B)(4). DIAGNOSIS OR REASON FOR USE: ENDOMETRIAL ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239050 NOVASURE ENDOMETRIAL ABLATION DEVICE MNB HOLOGIC INC. NS2000US 13M02RB

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR