BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 2426132 · Received January 11, 2012

    Report

    Report Number
    MW5023921
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 23, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE NOVA SURE LIST NUMBER (B)(4), LOT 11F16RA, EXP 07/2012 FAILED TO ACTIVATE AFTER 4 ATTEMPTS. A SECOND UNIT WAS OPENED (SAME ITEM NUMBER, LOT AND EXP NUMBER) AND THE UNIT ACTIVATED ON THE FIRST ATTEMPT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DISPOSABLE DEVICE KIT MNB HOLOGIC, INC. 11F16RA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR