BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR WITH CYTO

    MDR report key: 155620 · Received March 6, 1998

    Report

    Report Number
    2424102-1998-00001
    Event Type
    Other
    Date Received
    March 6, 1998
    Date of Event
    February 10, 1998
    Manufacturer
    TREX MEDICAL CORP., BENNETT DIVISION
    Product Code
    IZH
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT THE PINS SHEARED OFF AND THE BUCKY FELL OFF ONE OF THE MAMMOGRAPHY MACHINES. COMPLAINANT STATED THAT THERE WAS NO INJURY INVOLVED, BUT THAT THERE COULD VERY WELL HAVE BEEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other