BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR MAMMOGRAPHY SYS

    MDR report key: 187579 · Received September 15, 1998

    Report

    Report Number
    2424102-1998-00004
    Event Type
    Other
    Date Received
    September 15, 1998
    Date of Event
    September 1, 1998
    Report Date
    September 14, 1998
    Manufacturer
    TREX MEDICAL CORP., BENNETT DIV.
    Product Code
    IZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PATIENT WAS BEING POSITIONED FOR A MLO MAMMOGRAM, FOOT PEDAL OF THE MAMMOGRAPHY MACHINE STUCK IN UP POSITION AND LIFTED THE PATIENT BY HER ARM DURING UPWARD MOVEMENT OF C-ARM OF THE MACHINE. DURING LIFTING, THE PATIENT'S ARM WAS BRUISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR MAMMOGRAPHY SYS MAMMOGRAPHY SYS IZH TREX MEDICAL CORP., BENNETT DIV. M-CTR *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other