BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOGRAPHIC EQUIPMENT

    MDR report key: 697976 · Received April 7, 2006

    Report

    Report Number
    1418957-2006-00003
    Event Type
    Malfunction
    Date Received
    April 7, 2006
    Date of Event
    December 29, 2005
    Report Date
    April 7, 2006
    Manufacturer
    FISCHER IMAGING
    Product Code
    IYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TRAUMEX BUCKEY CASSETTE TRAY END STOP FAILED TO PREVENT THE TRAY FROM EXITING THE BUCKEY. THE TRAY FELL AND STRUCK THE TECHNOLOGIST'S FOOT, RESULTING IN A BROKEN TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOGRAPHIC EQUIPMENT DX TRAUMEX IYB FISCHER IMAGING UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention