BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 505407 · Received January 8, 2004

    Report

    Report Number
    2246315-2004-00001
    Event Type
    Injury
    Date Received
    January 8, 2004
    Date of Event
    December 1, 2003
    Report Date
    January 7, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED IN DEC. 2003, FROM AN ORTHOPEDIC SURGEON REGARDING AN UNIDENTIFIED PT WITH A HISTORY OF RHEUMATOID ARTHRITIS. THE PT WAS ADMINISTERED A SYNVISC INJECTION IN AN UNSPECIFIED KNEE AND EXPERIENCED A SEVERE INFLAMMATORY REACTION. A CULTURE TAKEN FROM A "BIG EFFUSION" SHOWED NO INFECTION OR CRYSTALS. A LAVAGE AND WASHOUT OF THE KNEE WAS PERFORMED. AT THE TIME OF THIS REPORT, THE PT'S CLINICAL OUTCOME IS UNK. SYNVISC IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, (E.G. ACETAMINOPHEN).

    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 UNKNOWN Required Intervention