BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 507423 · Received January 21, 2004

    Report

    Report Number
    2246315-2004-00008
    Event Type
    Injury
    Date Received
    January 21, 2004
    Date of Event
    January 1, 2001
    Report Date
    January 20, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEFT KNEE EFFUSION. INFO WAS RECEIVED FROM PT WITH A HISTORY OF OSTEOARTHRITIS OF BOTH KNEES, DIABETES, DEPRESSION, ATRIAL FIBRILLATION, BACK PROBLEMS, GASTRITIS AND ALLERGIES. THE PT HAS NO KNOWN ALLERGIES TO CHICKEN PRODUCTS. THE PT RECEIVED THEIR FIRST SERIES OF SYNVIC INJECTIONS TO THE LEFT KNEE APPROX TWO YEARS AGO. AFTER THE THIRD INJECTION, THE PHYSICIAN DRAINED FLUID FROM THE PT'S KNEE. THE PT WAS TREATED WITH AN INJECTION OF HYDROCORTISONE (DOSE UNK) AND EXPERIENCED PAIN RELIEF FOR ONE AND A HALF YEARS. AT THE TIME OF THIS REPORT, THE PT HAS RECOVERED. REFER TO SYNV-13439 FOR OTHER ADVERSE EVENTS EXPERIENCED BY THIS PT. QA EVAL RESULTS: THE REVIEW OF SYNVISC PRODUCT RELEASE DATA FOR BOTH THE US AND CANADA FACILITIES DID NOT INDICATE TRENDS THAT COULD BE ASSOCIATED TO ANY PRODUCT COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 MOZ GENZYME CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention