BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1222205 · Received November 5, 2008

    Report

    Report Number
    MW5008890
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 5, 2008
    Manufacturer
    CYTYC LTD. PARTNERSHIP
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRIOR TO BEGINNING AN ENDOMETRIAL ABLATION, THE PHYSICIAN TRIED TO DEPLOY THE DISPOSABLE DEVICE AND WAS UNABLE TO... A NEW DEVICE WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE NOVASURE 2000 MKN CYTYC LTD. PARTNERSHIP NS2000 08A28HB

    Patients

    Seq Age Sex Outcome Treatment
    1