BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOTHERAPY SYSTEM

    MDR report key: 4995139 · Received August 5, 2015

    Report

    Report Number
    3003873069-2015-00001
    Event Type
    Injury
    Date Received
    August 5, 2015
    Manufacturer
    TOMOTHERAPY
    Product Code
    MUJ
    PMA / PMN Number
    K112776
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE ACCURAY CURRENTLY CANNOT RULE OUT THE POSSIBILITY THAT THE TOMOTHERAPY SYSTEM CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT, ACCURAY HAS NOT OBTAINED ANY INFORMATION TO DATE THAT LEADS ACCURAY TO BELIEVE THAT THE TOMOTHERAPY SYSTEM CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. THE COMPANY IS THUS SUBMITTING THIS MDR IN AN ABUNDANCE OF THE CAUTION AND TO COMPLY FULLY WITH FDAS REQUIREMENTS AND EXPECTATIONS UNDER 21 CFR PART 803.

    Description of Event or Problem · 1

    AN ACCURAY EMPLOYEE FOUND AN ARTICLE TITLED "RADIATION ERRORS INVESTIGATED AT(B)(6); SOME EMPLOYEES DISCIPLINED". THE ARTICLE "NOTED...SOME PATIENTS AT (B)(6) RECEIVED IMPROPER DOSES OF RADIATION.."; AND "AT LEASE ONE RECEIVED DOSES THAT CAUSED SERIOUS COMPLICATIONS." IN SEPARATE ARTICLE RELATED TO THE SUBJECT, TITLED: CENTRACARE ACKNOWLEDGES MISTREATMENT OF CANCER PATIENTS", THE CEO OF THE (B)(6) STATED "...THERE WAS NOTHING WRONG WITH THE RADIATION EQUIPMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518963 TOMOTHERAPY SYSTEM TOMOTHERAPY SYSTEM MUJ TOMOTHERAPY 1018286 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability