BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1052034 · Received May 12, 2008

    Report

    Report Number
    1052034
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 12, 2008
    Manufacturer
    CYTYC SURGICALSERVICES, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOVASURE ABLATION HANDPIECE - PLASTIC SHEATH MADE AN ACCORDIAN APPEARANCE UPON REMOVAL OF DEVICE (CLOSURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE CATHETER, ABLATION, ENDOMETRIAL MNB CYTYC SURGICALSERVICES, INC. * 07K30HA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR