BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIQ

    MDR report key: 15834431 · Received November 18, 2022

    Report

    Report Number
    MW5113387
    Event Type
    Injury
    Date Received
    November 18, 2022
    Date of Event
    August 11, 2022
    Report Date
    November 16, 2022
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENTS RADIATION TREATMENT WAS DELIVERED TO THE WRONG LOCATION DUE TO CONFUSION ABOUT THE FACT THE TREATMENT BEAM ISOCENTER DIFFERED FROM THE IMAGING ISOCENTER USED FOR PATIENT SETUP. AS A RESULT, RADIATION BEAMS WERE DELIVERED 2CM AWAY FROM THE INTENDED TARGET. THIS RESULTED IN LACK OF COVERAGE OF THE TARGET BY THE RADIATION DOSE AND TREATMENT OF AN UNINVOLVED AREA. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371400 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB MOSAIQ 2.81

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other ISOCENTER