BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTX-3100

    MDR report key: 303390 · Received October 31, 2000

    Report

    Report Number
    1525965-2000-00003
    Event Type
    Injury
    Date Received
    October 31, 2000
    Date of Event
    July 10, 2000
    Report Date
    September 29, 2000
    Manufacturer
    MARCONI MEDICAL SYSTEMS, INC.
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER MEDWATCH REPORT 39006-2000-0007 FROM CUSTOMER: PT SUFFERED RADIATION BURN AS RESULT OF FLUOROSCOPY. REQUIRED MEDICAL INTERVENTION. NO PROBLEM WAS FOUND WITH THE SYSTEM AND NO OTHER REPORTS OF THIS TYPE HAVE BEEN REPORTED ON THIS EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTX-3100 X-RAY CONTROL IZO MARCONI MEDICAL SYSTEMS, INC. 003915 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention