BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 4236968 · Received October 31, 2014

    Report

    Report Number
    2246315-2014-45751
    Date Received
    October 31, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 22, 2014
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2014 FROM A PHYSICIAN. THIS CASE IS CROSS-REFERENCED WITH CASE (B)(4). THIS CASE INVOLVES A PATIENT (UNK DEMOGRAPHICS) WHO DEVELOPED SWELLING, SORENESS AND FLU LIKE SYMPTOMS AFTER RECEIVING TREATMENT WITH SYNVISC. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR SWELLING, SORENESS AND FLU-LIKE SYMPTOMS THAT OCCURRED WITH SYNVISC-ONE SEVERAL YEARS AGO. THE PATIENT'S PREVIOUS MEDICATIONS, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE NOT REPORTED. ON (B)(6) 2014, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION AT A DOSE OF 2 ML (FREQUENCY, INDICATION, BATCH/LOT NO., EXPIRATION DATE: NOT REPORTED). THE SAME DAY, THE PATIENT EXPERIENCED SWELLING, SEVERE SORENESS AND SEVERE FLU LIKE SYMPTOMS AFTER RECEIVING SYNVISC INJECTION. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: UNK FOR ALL THE EVENTS. OUTCOME: UNK FOR ALL 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
    698320 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK

    Patients

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