BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FDR GO PLUS E

    MDR report key: 15243396 · Received August 17, 2022

    Report

    Report Number
    1000513161-2022-00011
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    August 8, 2022
    Report Date
    August 17, 2022
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    UDI-DI
    0540217059379
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT THE USER CUT HIS FINGER WHEN HE CRASHED THE X-RAY UNIT INTO A DOOR AND WAS REQUIRED TO HAVE STITCHES AND A TETANUS SHOT ADMINISTERED. THE USER'S INJURY WAS TREATED AND NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED TO BE REQUIRED. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WAS NO DEATH REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156632 FDR GO PLUS E SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION N/A N/A 0540217059379

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention