BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3833664 · Received May 21, 2014

    Report

    Report Number
    MW5036215
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 13, 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 IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DEVICE WOULD NOT FUNCTION. A SUBSEQUENT "LIKE' DEVICE WAS UTILIZED WITHOUT INCIDENT. NOVASURE REPRESENTATIVE (B)(4) PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301473 NOVASURE ENDOMETRIAL ABLATION DEVICE MNB HOLOGIC INC. NS2000US 13M18R

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR