BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 4092238 · Received August 3, 2014

    Report

    Report Number
    2246315-2014-10601
    Event Type
    Injury
    Date Received
    August 3, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 11, 2014
    Manufacturer
    GENZYME CORPORATION (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS REC'D ON (B)(6) 2014 FROM A PHYSICIAN. THIS CASE WAS CROSS-REFERENCED WITH CASE (B)(4) (CLUSTER CASE). THIS CASE INVOLVES A (B)(6) FEMALE PT WHO EXPERIENCED REACTIVE EFFUSION AND KNEE SWELLING AFTER RECEIVING TREATMENT WITH SYNVISC. NO PAST DRUGS, MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE REPORTED. ON (B)(6) 2014, THE PT INITIATED TREATMENT WITH SYNVISC INJECTION (ROUTE AND FREQUENCY NOT PROVIDED, BATCH/LOT NUMBER: W1209 AND EXPIRY DATE: NOT PROVIDED) INTO AN UNSPECIFIED KNEE, FOR KNEE ARTHROSIS. ON (B)(6) 2014 SECOND INJECTION OF SYNVIS WAS REC'D. ON AN UNSPECIFIED DATE IN (B)(6) 2014, THE PT EXPERIENCED REACTIVE EFFUSION AND KNEE SWELLING. IT WAS REPORTED THAT THE PT WAS EXAMINED IN HOSPITAL AND THE REACTION WAS ON-GOING AT THE TIME OF THE REPORT. ACTION TAKEN: UNK. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: NOT RECOVERED FOR BOTH EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4) AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERION: HOSPITALIZATION FOR BOTH EVENTS. SEE SCANNED PAGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453105 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION (RIDGEFIELD) W1209

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R PREV MEDS = UNK| CON MEDS = UNK