BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM

    MDR report key: 512930 · Received February 6, 2004

    Report

    Report Number
    MW1031138
    Event Type
    Injury
    Date Received
    February 6, 2004
    Date of Event
    February 4, 2004
    Report Date
    February 6, 2004
    Manufacturer
    PROXIMA THERAPEUTICS
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUBJECT IS STATUS POST CRANIOTOMY/GLIASITE PLACEMENT FOR GBM 2003, BRACHYTHERAPY, AND EXTERNAL BEAM RADIATION THERAPY. THIS WAS NOT AN EMERGENCY ADMISSION. THE SUBJECT HAD SCHEDULED RESECTION OF RECURRENT TUMOR BY DR. AND COMPLETED ALL PRE-REQUISITE PROCEDURES PER THE HOSPITAL STANDARD OF CARE. SERIAL MRIS SHOW MARKED INTERVAL WORSENING OF EXTENSIVE T2 SIGNAL ABNORMALITY SURROUNDING THE SURGICAL CAVITY IN THE RIGHT TEMPORAL LOBE. ABNORMAL ENHANCEMENT IS ALSO MARKEDLY WORSENED IN A NODULAR AND IRREGULAR FASHION AROUND THE CAVITY. SUBJECT HAS HAD INCREASED SEIZURE ACTIVITY SINCE 12/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIASITE RADIATION THERAPY SYSTEM IOTREX BRACHYTHERAPY KXK PROXIMA THERAPEUTICS * M20526

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization