BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC

    MDR report key: 5018315 · Received July 31, 2015

    Report

    Report Number
    MW5055546
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 30, 2015
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WOULD NOT PASS CAVITY ASSESSMENT. TRIED FOUR TIMES WITH TWO DIFFERENT MACHINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501899 HOLOGIC NOVASURE DEVICE MNB HOLOGIC

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR