BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3842662 · Received May 16, 2014

    Report

    Report Number
    2246315-2014-59778
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(4) 2014 FROM A CONSUMER. THIS CASE CONCERNS A (B)(6) YEAR OLD MALE PT WHO DEVELOPED RIGHT KNEE INFLAMMATION, "DRAINED ABOUT 70 CC OF CLEAR, YELLOWISH FLUID OUT OF RIGHT KNEE" AND "COULD NOT PUT WEIGHT ON KNEE" AFTER RECEIVING TREATMENT WITH SYNVISC. THE PT HAD HISTORY OF SURGERY TO REMOVE HIS RIGHT MEDIAL MEDICUS AND HAD PREVIOUSLY RECEIVED SYNVISC (THREE INJECTIONS SIX MONTHS AGO AND HAD GREAT EXPERIENCE). NO CONCURRENT CONDITION OR CONCOMITANT MEDICATION WAS REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2014, FOUR WEEKS AGO, THE PT INITIATED TREATMENT WITH SECOND SERIES OF SYNVISC INJECTION (ROUTE, DOSE, BATCH/LOT NUMBER AND EXPIRATION DATE UNK) WEEKLY FOR OSTEOARTHRITIS. IT WAS REPORTED THAT THE FIRST INJECTION LATERAL SIDE OF THE KNEE AND WAS FINE. ON AN UNSPECIFIED DATE IN (B)(6) 2014, FOLLOWING THE SECOND SYNVISC INJECTION IN HIS RIGHT KNEE, THE PT DEVELOPED SWELLING AND INFLAMMATION. ON AN UNSPECIFIED DATE IN (B)(6) 2014, 70 CC OF CLEAR, YELLOWISH FLUID WAS DRAINED OUT OF THE KNEE AND THE PT WAS ADMINISTERED THE THIRD INJECTION. NO EVAL OF THE EFFUSION FLUID WAS PERFORMED. IT WAS REPORTED THAT THE SECOND AND THIRD INJECTIONS WERE GIVEN ON THE MEDIAL SIDE OF THE KNEE. ABOUT 6-7 HOURS LATER (BETWEEN 4:30 TO 11:00 PM) THE PT'S RIGHT KNEE BLEW UP AND HE COULD NOT PUT ANY WEIGHT ON THE KNEE. ON (B)(6) 2014, THE PT HAD SURGERY TO CLEAN IT OUT. ACTION TAKEN: NO ACTION TAKEN. OUTCOME: RECOVERED/RESOLVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERION: HOSPITALIZATION AND INTERVENTION REQUIRED FOR THE EVENTS OF RIGHT KNEE INFLAMMATION AND DRAINED ABOUT 70 CC OF CLEAR, YELLOWISH FLUID OUT OF RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293012 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R SYNVISC (PREV.) UNK| CON MEDS = UNK