BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 509367 · Received January 28, 2004

    Report

    Report Number
    2246315-2004-00012
    Event Type
    Injury
    Date Received
    January 28, 2004
    Date of Event
    January 1, 2003
    Report Date
    January 28, 2004
    Manufacturer
    GENZYME CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED IN 1/2004 FROM A PT WHO RECEIVED A SERIES OF SYNVISC INJECTIONS TO BOTH KNEES WITHIN A PERIOD OF SIX WEEKS (DATES UNK). AFTER THE SIXTH INJECTION, BOTH KNEES BECAME SWOLLEN AND THE PT EXPERIENCED A RISE IN TEMPERATURE. IN 12/2003, THE PT CONSULTED AN EMERGENCY ROOM PHYSICIAN. THE PHYSICIAN TREATED THE PT WITH A CORTISONE INJECTION AND PRESCRIBED VOLTAREN FOR BOTH ORAL AND TOPICAL USE. AT THE TIME OF THIS REPORT, THE SWELLING IS INCREASING, EVEN THOUGH IT HAD IMPROVED THE DAY BEFORE (12/2003). QA EVAL RESULTS: THE REVIEW OF SYNVISC PRODUCT RELEASE DATA FOR BOTH 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 CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention