BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT POWER INJECTOR SYSTEM

    MDR report key: 1852403 · Received September 28, 2010

    Report

    Report Number
    1518293-2010-00118
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6): COVIDIEN (B)(4) REGULATORY AFFAIRS REPORTS REC'D VIA FAX, A (B)(4) FEMALE PT, WITH AN UNK MEDICAL HISTORY AND DELICATE VEINS, REC'D A SINGLE DOSE OF OPTIJECT 350, BY IV ROUTE VIA A POWER INJECTOR AT A RATE OF 4.5ML/SECOND FOR A HEART CT SCAN FOR AN UNK INDICATION, 2 WEEKS AGO (IN (B)(6) 2010). AFTER OPTIJECT 350 INJECTION, THE PT EXPERIENCED AN INJECTION SITE EXTRAVASATION (TOP OF THE HAND) OF 120ML OF OPTIJECT. PT HOSPITALIZATION WAS PROLONGED AND THE PT IS CURRENTLY IN TREATMENT BY A SURGEON. ON (B)(6): PT WAS TREATED WITH HAND ELEVATION, ICE COMPRESS, HIRUDOID OINTMENT (MUCOPOLYSACCHARIDE POLYSULFATE). PT WAS REFERRED TO PLASTIC SURGEON, FINAL OUTCOME IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT POWER INJECTOR SYSTEM CT POWER INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM CO NOT REPORTED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention