BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAMMOLUX 1360

    MDR report key: 690609 · Received March 21, 2006

    Report

    Report Number
    2953690-2006-00001
    Event Type
    Other
    Date Received
    March 21, 2006
    Date of Event
    February 20, 2006
    Report Date
    March 20, 2006
    Manufacturer
    R2 TECHNOLOGY, INC.
    Product Code
    IXC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING ONE OF THESE PROCESSES THE TECHNICIAN'S ATTENTION WAS DIVERTED AND HER ARM WAS CAUGHT IN THE UPPER BELT INTAKE AREA. THE MOTORIZED VIEWER SHUT OFF AUTOMATICALLY. ONCE THE VIEWER WAS STOPPED, THE TECH WAS ABLE TO REMOVE HER ARM. THE TECH REPORTED "SOFT TISSUE DAMAGE" (BRUISING) TO HER ARM. HER ARM WAS PLACED IN A SLING. SHE MISSED TWO DAYS OF WORK BEFORE RETURNING TO NORMAL DUTIES. THE TECHNICIAN'S INJURY HAS SINCE RESOLVED COMPLETELY. THE DEVICE IS LABELED USING INTERNATIONAL SYMBOLOGY WARNING USER TO BE AWARE OF THE DANGER OF GETTING HANDS CAUGHT IN THE MOVING PARTS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOLUX 1360 MOTORIZED X-RAY VIEWER IXC R2 TECHNOLOGY, INC. MLX 1360 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other