BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPOWER CT INJECTOR SYSTEM

    MDR report key: 505084 · Received December 17, 2003

    Report

    Report Number
    2411512-2003-00013
    Event Type
    Malfunction
    Date Received
    December 17, 2003
    Date of Event
    November 13, 2003
    Report Date
    November 18, 2003
    Manufacturer
    E-Z-EM, INC.
    Product Code
    JAK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPOWER CT INJECTOR SYSTEM CT INJECTOR SYSTEM WITH EDA JAK E-Z-EM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other BERLEX (ULTRAVIST 300) NON-IONIC CONTRAST, 22| GAUGE ANGIOCATH (MANUFACTURER UNKNOWN).