BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 582259 · Received March 15, 2005

    Report

    Report Number
    2246315-2005-00020
    Event Type
    Injury
    Date Received
    March 15, 2005
    Date of Event
    February 10, 2005
    Report Date
    February 18, 2005
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WITH A MEDICAL HISTORY OF OSTEOARTHRITIS AND NO PREVIOUS SYNVISC TREATMENT, WHO EXPERIENCED RIGHT KNEE SWELLING AND DIFFICULTY WALKING. PT BEGAN A TREATMENT WITH SYNVISC IN FEBRUARY 2005. THE PT RECEIVED A SERIES OF THREE INJECTIONS OF SYNVISC INTO THE RIGHT KNEE IN FEBRUARY 2005 (LAST INJECTION IN 2005). PT REPORTED THAT THE KNEE WAS A"LITTLE BIGGER" BEFORE THE THIRD INJECTION IN 2005. 24 HOURS AFTER THE THIRD INJECTION, THE RIGHT KNEE BECAME "QUITE A BIT" SWOLLEN AND THE PT EXPERIENCED DIFFICULTY WALKING. PT RECEIVED A "CORTISONE" INJECTION IN THE RIGHT KNEE AT THE SAME TIME AS SYNVISC IN 2005. THE PT'S PHYSICIAN DECIDED NOT TO REMOVE THE FLUID FROM THE KNEE BECAUSE THE PT WAS CONCERNED THAT PT WOULD "LOOSE" THE LAST SYNVISC DOSE RECEIVED. AT THE TIME OF THIS REPORT, THE PT'S OUTCOME WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R