BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1883578 · Received October 12, 2010

    Report

    Report Number
    1883578
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 12, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOVASURE CONSOLE REPORTED "VACUUM" - BLOOD ENTERED THE DIAL OF THE HANDPIECE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================N/A====================== MANUFACTURER RESPONSE FOR NOVASURE, NOVASURE======================IT WILL BE SENT OUT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE NOVASURE MNB HOLOGIC * 10E04RA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NO OTHER THERAPIES