BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLIASITE RADIATION THERAPY SYSTEM (RTS)

    MDR report key: 558528 · Received December 7, 2004

    Report

    Report Number
    1067103-2004-00015
    Event Type
    Other
    Date Received
    December 7, 2004
    Date of Event
    November 6, 2004
    Report Date
    November 8, 2004
    Manufacturer
    PROXIMA THERAPEUTICS, INC.
    Product Code
    IWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RETRIEVAL OF IOTREX WAS SCHEDULED FOR 6:25PM 11/2004. IOTREX WAS REMOVED AT 11:00AM THE NEXT DAY PATIENT RECEIVED 74 GY AT 0.5 CM RATHER THAN THE PRESCRIBED DOSE OF 60 GY AT 0.5CM. THIS OCCURRED BECAUSE OF AN OVERSIGHT BY THE RADIATION ONCOLOGIST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R