BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE

    MDR report key: 2994405 · Received March 1, 2013

    Report

    Report Number
    MW5029257
    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 DID NOT PASS CAVITY TEST AFTER THREE ATTEMPTS. DIAGNOSIS OR REASONS FOR USE: DYSFUNCTIONAL UTERINE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89380 NOVASURE NOVASURE MNB HOLOGIC, INC. NS2000 12K25RA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention