BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC ONE (SYNVISC ONE)

    MDR report key: 3536651 · Received November 20, 2013

    Report

    Report Number
    2246315-2013-17368
    Date Received
    November 20, 2013
    Date of Event
    September 26, 2013
    Report Date
    November 12, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM (B)(6) ON (B)(6) 2013 FROM A CONSUMER. THIS CASE CONCERNS A FEMALE PT (AGE NOT PROVIDED) WHO DEVELOPED RIGHT KNEE INFLAMMATION, DIFFICULTY CLIMBING STAIRS, UNABLE TO GO ABOUT DAILY ACTIVITIES AND MODERATE TO SEVERE RIGHT KNEE PAIN AFTER RECEIVING SYNVISC ONE. THE PT'S MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATION OR CONCURRENT CONDITIONS WERE NOT REPORTED. ON (B)(6) 2013, THE PT RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AT A DOSE OF 6 ML, ONCE (ROUTE, LOT NUMBER AND EXPIRATION DATE UNK) FOR OSTEOARTHRITIS OF RIGHT KNEE. ON THE SAME DAY, PT EXPERIENCED MODERATE TO SEVERE PAIN AND INFLAMMATION. PT ALSO STATED THAT AFTER THE INJECTION HER CONDITION WORSENED AND HAD DIFFICULTY IN CLIMBING STAIRS. ALSO SHE WAS UNABLE TO GO ABOUT DAILY ACTIVITIES. ACTION TAKEN: NO ACTION TAKEN. CORRECTIVE TREATMENT: LASER ACUPUNCTURE FOR ALL THE EVENTS. OUTCOME: UNK FOR ALL THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602249 SYNVISC ONE (SYNVISC ONE) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 PREV MEDS - UNK| CON MEDS - UNK