BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM

    MDR report key: 514257 · Received February 19, 2004

    Report

    Report Number
    MW1031323
    Event Type
    Injury
    Date Received
    February 19, 2004
    Date of Event
    February 17, 2004
    Report Date
    February 19, 2004
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH GLIOBLASTOMA MULTIFORME STATUS POST RIGHT FRONTAL CRANIOTOMY IN 2003, BRACHYTHERAPY VIA GLIASITE IN 2003 AND EXTERNAL BEAM RADIATION IN 2003. SUBJECT BEGAN EXPERIENCING URINARY INCONTINENCE AND GAIT INSTABILITY IN 2004 PER FAMILY. FAMILY MEMBER BROUGHT SUBJECT TO ER IN 2004 AFTER SEVERAL DAYS OF INCREASING LETHARGY. HEAD CT REVEALED HYDROCEPHALUS. THE SUBJECT HAD A VP SHUNT PLACED IN 2004. THE RELATIONSHIP OF HYDROCEPHALUS TO THE GLIASITE DEVICE IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIASITE RADIATION THERAPY SYSTEM IOTREX BRACHYTHERAPY KXK PROXIMA THERAPEUTICS, INC. * M20527

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization