BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LORAD M III MAMMOGRAPHY

    MDR report key: 80341 · Received March 27, 1997

    Report

    Report Number
    80341
    Event Type
    Malfunction
    Date Received
    March 27, 1997
    Date of Event
    October 11, 1996
    Report Date
    October 17, 1996
    Manufacturer
    LORAD TREX MEDICAL CORP.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT HAD BURNS ON HER CHEST THAT CORRESPOND TO THE THREE SCREW HEADS ON THE END OF THE MAMMOGRAPHY BUCKY. PT WAS HAVING A NEEDLE PLACEMENT MAMMOGRAPHY. FOUND 15VDC ON SCREW HEADS OF THE BUCKY. FOUND 15VDC WIRE PINCHED AND SHORTED TO FRAME OF BUCKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORAD M III MAMMOGRAPHY MAMMOGRAPHY UNIT IZH LORAD TREX MEDICAL CORP. M III NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other