BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOSITE

    MDR report key: 1294308 · Received January 19, 2009

    Report

    Report Number
    1294308
    Event Type
    Malfunction
    Date Received
    January 19, 2009
    Date of Event
    January 15, 2009
    Report Date
    January 19, 2009
    Manufacturer
    CYTYC SURGICAL SERVICES, INC.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN OR FOR RE-EXCISION OF A RIGHT BREAST LUMPECTOMY. WHEN BREAST OPENED, NOTED MAMMOSITE BALLOON CATHETER WAS RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOSITE CATHETER, BRACHYTHERAPY, BREAST JAQ CYTYC SURGICAL SERVICES, INC. 2456 08F24HB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR