BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 3893814 · Received June 12, 2014

    Report

    Report Number
    2246315-2014-75042
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2014 FROM AN INTERNIST VIA OUR MARKETING PARTNER (B)(4). THIS CASE CONCERNS A (B)(6) Y/O MALE PT WHO EXPERIENCED PAIN IN BOTH KNEE AFTER RECEIVING TREATMENT WITH SYNVISC INJECTION. NO RELEVANT MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON (B)(6) 2014, THE PT STARTED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION, AT A DOSE OF 02 ML, WEEKLY, (BATCH/LOT NUMBER AND EXPIRATION DATE: UNK) INTO UNSPECIFIED LOCATION FOR GONARTHROSIS. ON (B)(6) 2014, PT RECEIVED THIRD DOSE OF SYNVISC INJECTION. ON THE SAME DAY, SHE COMPLAINED PAIN IN BOTH KNEES. ON (B)(6) 2014, SHE VISITED THE REPORTING HOSPITAL AND UNDERWENT ARTHROCENTESIS IN BOTH KNEES WHICH WAS SUBMITTED FOR SYNOVIAL FLUID CULTURE. ON AN UNK DATE IN (B)(6) 2014, PT RECEIVED CORTICOSTEROID NOS (STEROID). IT WAS REPORTED THAT SYNVISC THERAPY WAS DISCONTINUED WITH FINAL DOSE ON (B)(6) 2014. OUTCOME: NOT RECOVERED/ NOT RESOLVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERION: INTERVENTION REQUIRED. REPORTING INTERNIST'S CAUSALITY ASSESSMENT: PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348884 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention PREV MEDS = UNK| CON MEDS = UNK