BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 2862308 · Received November 27, 2012

    Report

    Report Number
    2862308
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 27, 2012
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC * 12E04R
    1 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. * 12E04R

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR