BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3940207 · Received June 19, 2014

    Report

    Report Number
    2246315-2014-74984
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 23, 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

    Additional Manufacturer Narrative · 1

    A PHARMACEUTICAL TECHNICAL COMPLAINT WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(4) 2014: THIS CASE CONCERNS A PT WHO ALMOST PASSED OUT FROM THE PAIN AFTER RECEIVING SYNVISC FOR UNK INDICATION. ALTHOUGH THE ROLE OF DEVICE CANNOT BE RULED OUT BASED ON THE DEVICE EVENT TEMPORAL RELATIONSHIP; HOWEVER, LACK OF DETAILED INFO ABOUT MEDICAL HISTORY, LAB DATA, ANY CONCURRENT MEDICAL ILLNESS, CLINICAL COURSE ETC. OF THE PT PRECLUDED A COMPREHENSIVE ASSESSMENT IN THIS CASE.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM THE PT. THIS CASE INVOLVES AN ELDERLY (B)(6) PT WHO EXPERIENCED PAIN, ALMOST PASSED OUT FROM THE PAIN, FALL AND BOTH OF HER KNEES HURT (RIGHT MORE THAN LEFT) AFTER RECEIVING TREATMENT WITH SYNVISC. NO PAST DRUGS, MEDICAL HISTORY, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNK DATE IN 2013 (6-7 MONTHS AGO), THE PT RECEIVED TREATMENT WITH THREE SYNVISC INJECTION (DOSE, FREQUENCY, BATCH/LOT NUMBER AND EXPIRY DATE: NOT PROVIDED) INTO RIGHT KNEE FOR AN UNK INDICATION. IT WAS REPORTED THAT THE PT ALMOST PASSED OUT FROM THE PAIN. FURTHER, REPORTED THAT THE TREATMENT HELPED HER KNEE. ON AN UNK DATE IN (B)(6) 2014 (3-4 WKS AGO), THE PT FELL. IT WAS REPORTED THAT NOW BOTH OF HER KNEES HURT (RIGHT MORE THAN LEFT). IN ADDITION, IT WAS REPORTED THAT THE PT WAS TAKING NATURAL SUPPLEMENTS AND WAS PLANNING TO HAVE ANOTHER INJECTION IN HER KNEE(S). NO CORRECTIVE TREATMENT WAS REPORTED. OUTCOME: UNK FOR ALL THE EVENTS SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT FOR ALMOST PASSED OUT FROM THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359807 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CON MEDS = UNK| PREV MEDS = UNK