BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOSITE

    MDR report key: 1840214 · Received September 15, 2010

    Report

    Report Number
    MW5017476
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 15, 2010
    Manufacturer
    HOLOGIC
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 9/9, CED (CAVITY EVALUATION DEVICE) WAS PLACED (RIGHT BREAST). ON 9/14, RUPTURE OF DEVICE NOTED WITH EXTRAVASATION OF FLUID. RETURNED TO OPERATING ROOM FOR REMOVAL/REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOSITE CAVITY EVALUATION DEVICE JAQ HOLOGIC 9031

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR