BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOVUE-370

    MDR report key: 1920510 · Received November 14, 2010

    Report

    Report Number
    1920510
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 14, 2010
    Manufacturer
    BRACCO DIAGNOSTICS
    Product Code
    KTA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOVUE-370 CONTRAST DYE KTA BRACCO DIAGNOSTICS NA 0B50299
    2 CONTRAST CONTROLLER; SPIKE ASSY CONTRAST CONTROLLER; SPIKE ASSY FPA NAVILYST MEDICAL, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR