BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE

    MDR report key: 2994291 · Received March 1, 2013

    Report

    Report Number
    MW5029241
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    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

    NOVASURE DEVICE WOULD NOT PASS CAVITY ASSESSMENT FOLLOWING ALL TROUBLE SHOOTING ATTEMPTS. A SECOND DEVICE WAS OPENED AND PASSED THE CAVITY ASSESSMENT ON THE FIRST ATTEMPT. DATE OF USE: (B)(6) 2013. REASON FOR USE: DYSFUNCTIONAL UTERINE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89457 NOVASURE NOVASURE MNB HOLOGIC, INC NS2007 12L27MA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention