BEUDAMED
    FDA Adverse Event Other Summary report: N

    CT9000 ADV ANGIOGRAPHIC INJECTOR

    MDR report key: 606798 · Received May 23, 2005

    Report

    Report Number
    1518293-2005-00016
    Event Type
    Other
    Date Received
    May 23, 2005
    Date of Event
    February 2, 2005
    Report Date
    April 27, 2005
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CTA CHEST WAS PERFORMED ON AN INPATIENT WITH EXISTING 18GA IV IN RIGHT AC. OPTIRAY 320 WAS INJECTED AT A RATE OF 3CC/SEC FOR A VOLUME OF 100CC. APPROX 60CC EXTRAVASATED, AREA MARKED, ARM ELEVATED, COOL PACK APPLIED, MD NOTIFIED, RN ASSESSED DAILY. PT EXPERIENCED NO FURTHER ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV ANGIOGRAPHIC INJECTOR ANGIOGRAPHIC INJECTOR AND SYRINGE DXT LIEBEL-FLARSHEIM CO. CT9000ADV *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other