BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOMOTHERAPY HI-ART SYSTEM

    MDR report key: 746541 · Received October 11, 2005

    Report

    Report Number
    MW1036903
    Event Type
    Other
    Date Received
    October 11, 2005
    Date of Event
    June 16, 2005
    Report Date
    September 14, 2005
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOMOTHERAPY HI-ART SYSTEM RADIATION IYE TOMOTHERAPY INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other