BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3960969 · Received July 23, 2014

    Report

    Report Number
    MW5037421
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    HOLOGIC
    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 NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DEVICE WOULD NOT PASS THE CAVITY TEST X 2 DEVICES. DATES OF USE: (B)(6) 2014 - (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: ENDOMETRIAL ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432093 NOVASURE NOVASURE MNB HOLOGIC NS2000US 14A20RD
    432094 NOVASURE NOVASURE MNB HOLOGIC NS2000US 14A30RB

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR