BEUDAMED
    FDA Adverse Event Other Summary report: N

    HI-ART SYSTEM

    MDR report key: 594270 · Received April 22, 2005

    Report

    Report Number
    3003873069-2005-00001
    Event Type
    Other
    Date Received
    April 22, 2005
    Date of Event
    March 23, 2005
    Report Date
    April 22, 2005
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    MUJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING PROSTATE TREATMENTS FOR ABOUT THREE MONTHS IN 2005. IT WAS VERBALLY REPORTED BY THE USER FACILITY THAT A DOSE HIGHER THAN PRESCRIBED WAS ADMINISTERED. ACCORDING TO THE USER FACILITY, THE PATIENT ENCOUNTERED NO ADVERSE EFFECTS ONE WEEK POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-ART SYSTEM INTENSITY MODULATED RADIATION THERAPY MUJ TOMOTHERAPY INCORPORATED H-0000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other