BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 408332 · Received July 31, 2002

    Report

    Report Number
    2246315-2002-00019
    Event Type
    Injury
    Date Received
    July 31, 2002
    Report Date
    July 29, 2002
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    ---
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    STAPHYLOCOCCUS AUREUS SEPTIC ARTHRITIS. INFO WAS RECEIVED IN THE FORM OF A PUBLISHED ARTICLE IN "CLINICAL ORTHOPAEDICS AND RELATED RESEARCH", BY J. DAVID EVANICH ET AL., NO. 390: 173 - 181, 2001, IT WAS REPORTED THAT ONE PT DEVELOPED STAPHYLOCOCCUS AUREUS SEPTIC ARTHRITIS TWO WEEKS AFTER RECEIVING AN INITIAL INJECTION OF SYNVISC INTO THE KNEE. THE PT WAS TREATED SUCCESFULLY WITH ARTHROSCOPIC LAVAGE AND EXTENDED ANTIBIOTIC THERAPY. THE QUALITY ASSURANCE GROUP EVALUATED PRODUCT RELEASE DATA, INCLUDING INTERMEDIATE PRODUCT, FOR BOTH U.S. AND CANADIAN FACILITIES AND NO ABNORMAL TRENDS WERE ASSOCIATED WITH ANY PRODUCT COMPLAINTS. ARTHROSCOPIC LAVAGE EXTENDED ANTIBIOTIC THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention