BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1213777 · Received October 28, 2008

    Report

    Report Number
    2246315-2008-00157
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PSEUDOSEPSIS [INFLAMMATION]. SWELLING IN KNEE [JOINT SWELLING]. KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 16-OCT-2008 AND 21-OCT-2008 FROM A PHYSICIAN REGARDING A MALE PATIENT, INITIALS AND AGE UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS UNKNOWN. THE PATIENT RECEIVED AN UNKNOWN NUMBER OF SYNVISC INJECTION(S) IN THE KNEE ON UNKNOWN DATE(S). THE PATIENT EXPERIENCED PSEUDOSEPSIS AND KNEE SWELLING. THE PATIENT WAS HOSPITALIZED ON THE DAY PRIOR TO ORIGINAL DATE. THE PATIENT HAD BROWN FLUID ASPIRATED FROM HIS KNEE WHICH HAD A WHITE BLOOD CELL COUNT OF 95000 AND WAS CULTURE NEGATIVE. THE PATIENT RECEIVED AN INTRA-ARTICULAR STEROID INJECTION, RESPONDED AND WAS DISCHARGED IN 2 DAYS. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT'S OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK U0817

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R