BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3922780 · Received June 20, 2014

    Report

    Report Number
    3922780
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT DID NOT PERFORM AS EXPECTED WHEN TRYING TO OPERATE IT. NOT SURE IF IT WAS THE MACHINE. ATTEMPTED TWO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363381 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. * 13K14R
    363382 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. * 13G09RC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR