BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRACHYVISION

    MDR report key: 1060387 · Received June 12, 2008

    Report

    Report Number
    1124791-2008-00001
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 12, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K992762
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VARIAN INFORMED BY NRC OF EVENTS AT A CUSTOMER SITE. A PHYSICIST WAS USING BRACHYVISION 6.5 AND MADE A MISTAKE WHEN HE DIGITIZED THE IMAGES FOR PLANNING. FOUR PTS WERE UNDER-DOSED THAT WERE BEING TREATED WITH LOW DOSE MANUAL BRACHYTHERAPY. THE RADIATION ONCOLOGIST SAID THAT THE PTS WILL BE RE-TREATED AND THERE WILL BE NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRACHYVISION BRACHYTHERAPY TREATMENT PLANNING SOFT MUJ VARIAN MEDICAL SYSTEMS 6.5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other