BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOJECTOR

    MDR report key: 365547 · Received December 11, 2001

    Report

    Report Number
    MW1023578
    Event Type
    Other
    Date Received
    December 11, 2001
    Date of Event
    October 22, 2001
    Report Date
    December 11, 2001
    Manufacturer
    BIOJECT, INC.
    Product Code
    KZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT, ON COUMADIN THERAPY, RECEIVED ANNUAL INFLUENZA VACCINATION. VACCINE WAS ADMINISTERED USING A JET INJECTION, NEEDLE-LESS SYSTEM. PT RETURNED TO CLINIC WITH ECCHYMOSIS TO RIGHT DELTOID. DIAGNOSED AS HETEROTROPIC OSSIFICATION. PT TO RECEIVE ORTHOPEADIC EVALUATION TO DETERMINE BEST TREATMENT FOR DISEASE PROCESS. THIS PROBLEM DID NOT PRESENT WITH ANY OTHER PTS BEFORE OR SINCE. RPTR ASKS IS THERE A WARNING OR PRECAUTION RELATED TO SETS OF PTS, SUCH AS A PT ON COUMADIN THERAPY. RPTR UNDERSTANDS THAT THE HCP MAY HAVE SELECTED AN INCORRECT SIZE INJECTOR NEEDLE. ALL HCPS HAD RECEIVED TRAINING AND WERE CURRENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55724 BIOJECTOR JET INJECTOR KZE BIOJECT, INC. BIOJECTOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other