BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOSITE CAVITY EVALUATION DEVICE

    MDR report key: 837350 · Received February 9, 2007

    Report

    Report Number
    3003407659-2007-00004
    Event Type
    Malfunction
    Date Received
    February 9, 2007
    Date of Event
    January 10, 2007
    Report Date
    January 11, 2007
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    KXK
    PMA / PMN Number
    k032067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT ARRIVED AT PHYSICIAN'S OFFICE TO EXCHANGE THE MAMMOSITE CAVITY EVALUATION DEVICE (CED) WITH THE MAMMOSITE RADIATION THERAPY SYSTEM. THE CED BALLOON SEPARATED FROM THE LUMEN DURING REMOVAL. THE CED BALLOON WAS REMOVED AND REPLACED WITH THE MAMMOSITE RADIATION THERAPY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOSITE CAVITY EVALUATION DEVICE SYSTEM, APPLICATOR RADIONUCLIDE, REMOTE KXK CYTYC SURGICAL PRODUCTS 919009 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention