BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOJECTOR B2000

    MDR report key: 804902 · Received January 8, 2007

    Report

    Report Number
    MW1041566
    Event Type
    Other
    Date Received
    January 8, 2007
    Date of Event
    December 28, 2006
    Report Date
    January 8, 2007
    Manufacturer
    BIOJECT MED TECHNOLOGIES, INC
    Product Code
    KZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    USE OF BIOJECTOR B2000 DEVICE FOR FUZEON SUBCUTANEOUS ADMINISTRATION CAUSED EXCESSIVE SITE BLEEDING. PT REPORTS SIMILAR ADVERSE EVENT WITH OTHER INJECTION DEVICES INCLUDING SMALL GAUGE INSULIN SYRINGES. ADVISED PT TO APPLY CONSTANT FIRM PRESSURE/COMPRESSION AT SITE AFTER INJECTION WITH GAUZE/TISSUE AND DO NOT RUB AREA. ALSO ADVISED TO CONTACT MD, IF CONTINUED BLEEDING EVENTS, TO CHECK FOR BLOOD/LIVER FUNCTION TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOJECTOR B2000 BIOJECTOR KZE BIOJECT MED TECHNOLOGIES, INC B2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other FUZEON 90MG ROCHE/TRIMERIS