BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIGITAL FLUOROSCOPY SYSTEM

    MDR report key: 193461 · Received October 15, 1998

    Report

    Report Number
    MW1014806
    Event Type
    Other
    Date Received
    October 15, 1998
    Date of Event
    September 1, 1996
    Report Date
    October 13, 1998
    Manufacturer
    TOSHIBA AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    IZG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CARDIAC CATHETERIZATION 9/13/96. ON 10/22/98 REFERRED TO DERMATOLOGY FOR "RASH ON BACK". IN 6/97 HAD ANOTHER CARDIAC CATHETERIZATION. CONTINUED TO BE SEEN BY DERMATOLOGY, AND IN 12/97 THE SUSPICION OF CHRONIC RADIATION DERMATITIS WAS RAISED. IT IS NOW FELT THAT THIS IS THE LIKELY DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL FLUOROSCOPY SYSTEM * IZG TOSHIBA AMERICAN MEDICAL SYSTEMS, INC. DFP 2000A *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other