BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICKER

    MDR report key: 303384 · Received October 31, 2000

    Report

    Report Number
    303384
    Event Type
    Injury
    Date Received
    October 31, 2000
    Date of Event
    July 10, 2000
    Report Date
    September 22, 2000
    Manufacturer
    MARCONI MEDICAL SYSTEMS WORLD HEADQUARTERS
    Product Code
    IZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT SUFFERED RADIATION BURN AS RESULT OF FLUOROSCOPY. REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICKER C ARM FLUOROSCOPY IZO MARCONI MEDICAL SYSTEMS WORLD HEADQUARTERS MTX-3100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention