BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 814167 · Received February 5, 2007

    Report

    Report Number
    2246315-2007-00006
    Event Type
    Injury
    Date Received
    February 5, 2007
    Date of Event
    January 1, 2005
    Report Date
    January 8, 2007
    Manufacturer
    *
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    SEVERE SWELLING, SYNOVIAL FLUID ACCUMULATION. INFO WAS RECEIVED ON 08-JAN-2007 REGARDING AN ARTICLE ENTITLED "TOLERABILITY AND SHORT-TERM EFFECTIVENESS OF HYLAN G-F 20 IN 4253 PTS WITH OSTEOARTHRITIS OF THE KNEE IN CLINICAL PRACTICE" CURRENT MEDICAL RESEARCH AND OPINIONS, VOL. 21, NO. 8, 2005, 1261-1269 (F. KEMPER, U. GEBHARDT, T. MENGURAND, C. MURRAY). THE ARTICLE DESCRIBED RESULTS FROM A PROSPECTIVE, OBSERVATIONAL STUDY CONDUCTED IN GERMANY ON UNSPECIFIED DATES IN 2005, WHEREIN 4253 PTS WITH OSTEOARTHRITIS OF THE KNEE WERE TREATED WITH THREE WEEKLY INTRA-ARTICULAR INJECTIONS OF SYNVISC AND OBSERVED FOR TOLERABILITY AND EFFECTIVENESS OF PAIN MGMT WITH SYNVISC THERAPY. PTS WERE ASKED TO ASSESS PAIN ON A 4-POINT SCALE BEFORE AND 3 WEEKS AFTER THE FIRST INJECTION. PT TREATMENT AND FOLLOW-UP WERE DOCUMENTED OVER 4 VISITS. ON AN UNK DATE IN 2005, ONE PT OF UNSPECIFIED GENDER AND AGE EXPERIENCED A SERIOUS ADVERSE EVENT OF SEVERE SWELLING AND SYNOVIAL FLUID ACCUMULATION ONE DAY AFTER INJECTION. THE PT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS AND ICE. THIS PT, WHO HAD A PREVIOUS HISTORY OF A LARGE KNEE EFFUSION AFTER TREATMENT WITH SYNVISC, RECOVERED SPONTANEOUSLY AFTER SYNOVIAL FLUID ASPIRATION. THIS LOCAL ADVERSE EVENT WAS JUDGED AS POSSIBLY RELATED TO SYNVISC. THERE WERE NO OTHER REPORTED SERIOUS ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ * NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization