BEUDAMED
    FDA Adverse Event Other Summary report: N

    SL SERIES

    MDR report key: 522213 · Received April 26, 2004

    Report

    Report Number
    9617016-2004-00008
    Event Type
    Other
    Date Received
    April 26, 2004
    Date of Event
    March 24, 2004
    Report Date
    April 26, 2004
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TREATMENT DELIVERED WITH AN OPEN FIELD RATHER THAN THE PLANNED WEDGED FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL SERIES DIGITAL LINEAR ACCELERATOR IYE ELEKTA LIMITED MRT 0512 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other