BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 506238 · Received January 12, 2004

    Report

    Report Number
    2246315-2004-00004
    Event Type
    Injury
    Date Received
    January 12, 2004
    Date of Event
    November 26, 2003
    Report Date
    January 12, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INCREASED KNEE PAIN, INCREASED KNEE STIFFNESS, KNEE SWELLING. INFO WAS RECEIVED IN DEC 2003 FROM A PHYSICIAN REGARDING A PT, WITH A HISTORY OF OSTEOARTHRITIS. THE PT RECEIVED A SERIES OF SYNVISC INJECTIONS (KNEE UNK) IN 2003. THE PHYSICIAN REMOVED FLUID PRIOR TO THE FIRST TWO INJECTIONS, BUT HE WAS UNABLE TO ASPIRATE FLUID PRIOR TO THE THIRD INJECTION. THE PT CONTACTED THE PHYSICIAN AND REPORTED INCREASED PAIN AND STIFFNESS IN BOTH KNEES. THE FOLLOWING MONTH, THE PHYSICIAN REPORTED THAT THE PT RECEIVED A SERIES OF SYNVISC INJECTIONS TO THE LEFT KNEE WITH BENEFIT SIX MONTHS PRIOR TO A SECOND SYNVISC SERIES. THE PHYSICIAN ALSO REPORTED THAT THE PT EXPERIENCED KNEE SWELLING AFTER THE SECOND SERIES OF SYNVISC. THE SYMPTOMS CLEARED PROMPTLY WITH AN INTRA-ARTICULAR CORTICOSTEROID INJECTION (DATE UNK). AT THE TIME OF THIS REPORT, THE PT HAS RECOVERED. QA EVALUATION RESULTS: THE REVIEW OF SYNVISC PRODUCT RELEASE DATA FOR THE US AND CANADIAN 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 75 YR Required Intervention