BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORAD M-IV MAMMOGRAPHY SYSTEM

    MDR report key: 505736 · Received January 8, 2004

    Report

    Report Number
    1220984-2004-00001
    Event Type
    Injury
    Date Received
    January 8, 2004
    Date of Event
    December 3, 2003
    Report Date
    January 7, 2004
    Manufacturer
    LORAD, A HOLOGIC CO.
    Product Code
    IZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A MAMMOGRAM POSITION CHANGE THE PATIENT WAS ASKED TO HOLD ON TO THE PATIENT HANDLE. THE PATIENT'S HAND INADVERTENTLY TOUCHED THE C-ARM RELEASE SWITCH CAUSING THE C-ARM TO TRAVEL, HITTING THE PATIENT IN THE UPPER AND MIDDLE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORAD M-IV MAMMOGRAPHY SYSTEM RADIOLOGY IZH LORAD, A HOLOGIC CO. M-IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization