BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS

    MDR report key: 174518 · Received June 22, 1998

    Report

    Report Number
    174518
    Event Type
    Other
    Date Received
    June 22, 1998
    Date of Event
    January 11, 1996
    Report Date
    May 13, 1998
    Manufacturer
    SIEMENS
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A DIAGNOSTIC LEFT HEART CATHERIZATION IN JAN 96; NOTICED INJURY TO UPPER LEFT SIDE OF BACK SEVERAL MONTHS FOLLOWING THE STUDY: PT WAS SEEN IN DERMATOLOGY ; INJURY DEVELOPED INTO A 8 X 8 CM OVAL LESION. DIAGNOSED IN APR 98 AS FLUOROSCOPIC INDUCED RADIATION DERMATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS FIXED FLUOROSCOPY IZO SIEMENS TUBE: 1684054V2157 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other