BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISCAN 300

    MDR report key: 917860 · Received September 20, 2007

    Report

    Report Number
    MW5003833
    Event Type
    Injury
    Date Received
    September 20, 2007
    Date of Event
    July 1, 2003
    Report Date
    September 20, 2007
    Manufacturer
    GE
    Product Code
    KTA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BIOPSY PROVEN NFD/NFS. UNKNOWN DATE OF BIOPSY GIVEN GADOLINIUM: 2003, 20CC OMNISCAN. THE FOLLOWING DAY, 30CC OMNISCAN DEVELOPED LEG PAIN AND RASH IN APPROX THREE MONTHS LATER, PRIOR TO DEVELOPMENT OF END STAGE RENAL DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISCAN 300 NONE KTA GE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Life Threatening