BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3833665 · Received May 21, 2014

    Report

    Report Number
    MW5036216
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 13, 2014
    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

    ATTEMPTED TO UTILIZE HOLOGIC INC NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DEVICE TWICE X 2 DEVICES WITH SAME LOT NUMBER BUT WERE UNABLE TO PROVIDE TREATMENT. NEITHER DEVICE WOULD PASS THE CAVITY ASSESSEMENTS WHICH WERE RE-CALCULATED AND RE-ADJUSTED EACH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301362 NOVASURE ENDOMETRIAL ABLATION DEVICE MNB HOLOGIC INC. NS2000US 13M18R
    301363 NOVSURE ENDOMETRIAL ABLATION DEVICE MNB HOLOGIC INC. NS2000US 13M18R

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR