BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM (RTS)

    MDR report key: 514725 · Received March 3, 2004

    Report

    Report Number
    75369-2004-00004
    Event Type
    Injury
    Date Received
    March 3, 2004
    Date of Event
    February 17, 2004
    Report Date
    February 20, 2004
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WITH GLIOBLASTOMA MULTIFORME STATUS POST RIGHT FRONTAL CRANIOTOMY 2003, BRACHYTHERAPY WITH THE DEVICE FOR A WEEK, AND EXTERNAL BEAM RADIATION FOR THIRTEEN AND HALF MONTHS. SUBJECT BEGAN EXPERIENCING URINARY INCONTINTENCE AND GAIT INSTABIITY IN 2004 PER FAMILY. PT WAS BROUGHT TO THE E.R. IN 2004 AFTER INCREASED LETHARGY. HEAD CT REVEALED HYDROCEPHALUS. THE PT HAD VP SHUNT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIASITE RADIATION THERAPY SYSTEM (RTS) BALLOON CATHETER, MANUAL RADIONUCLIDE APPLICATOR SYSTEM KXK PROXIMA THERAPEUTICS, INC. * M20527

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization