BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM (RTS)

    MDR report key: 509613 · Received February 2, 2004

    Report

    Report Number
    75369-2004-00002
    Event Type
    Injury
    Date Received
    February 2, 2004
    Date of Event
    November 18, 2003
    Report Date
    November 19, 2003
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    IWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IMPLANTED WITH DEVICE IN 2003. AT FOLLOW-UP VISIT TWO MONTHS LATER, MRI/CT IMAGING SHOWED EVIDENCE OF CEREBRAL EDEMA, COMMON TOXICITY GRADE 3. EVENT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIASITE RADIATION THERAPY SYSTEM (RTS) BALLOON CATHETER, MANUAL RADIONUCLIDE APPLICATOR SYSTEM IWJ PROXIMA THERAPEUTICS, INC. * 77359

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention