BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTYC MAMMOSITE

    MDR report key: 2202071 · Received August 5, 2011

    Report

    Report Number
    MW5021670
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 5, 2011
    Manufacturer
    HOLOGIC LP
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD MAMMOSITE RADIATION THERAPY SYSTEM, SPHERICAL APPLICATOR 4-5CM PLACED IN BREAST AFTER THE CED WAS REMOVED. THE PATIENT LEFT FACILITY AND ON WAY HOME HEARD A "POP". SHE AND MD SPOKE AND AGREED TO RETURN ON (B)(6) 2011. SHE RETURNED TO OUR HOSPITAL AND THE MAMMOSITE BALLOON WAS RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTYC MAMMOSITE MAMMOSITE SPHERICAL APPLICATOR TRAY 4-5CM JAQ HOLOGIC LP 2456 08M08H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR