BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOSITE

    MDR report key: 1633710 · Received March 10, 2010

    Report

    Report Number
    1633710
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    February 11, 2010
    Report Date
    March 10, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    MAMMOSITE CATHETER HAD A HOLE IN THE BALLOON. DID NOT REACH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOSITE CATHETER, BRACHYTHERAPY JAQ HOLOGIC, INC. 9031 09K08R

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR