BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3940666 · Received June 25, 2014

    Report

    Report Number
    2246315-2014-83145
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 19, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE WAS RECEIVED FROM UNITED STATES ON (B)(6), 2014 FROM A PHYSICIAN. THIS CASE WAS CROSS REFERENCED TO (B)(4). THIS CASE CONCERNS A PATIENT (DEMOGRAPHICS NOT PROVIDED) WHO PRESENTED WITH ACUTE INFLAMMATORY RESPONSE AFTER REVIEWING SYNVISC INJECTION. NO RELEVANT MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION (ROUTE, DOSAGE REGIMEN, BATCH/OT AND EXPIRATION DATE NOT PROVIDED) IN AN UNSPECIFIED LOCATION FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, AFTER UNKNOWN LATENCY, THE PATIENT PRESENTED WITH ACUTE INFLAMMATORY RESPONSE. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: STEROID INJECTION. OUTCOME: UNKNOWN. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND CONCLUSION WAS PENDING FOR THE SAME. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6), 2014: IN THIS CASE, THE PATIENT HAD ACUTE INFLAMMATORY RESPONSE TO SYNVISC FOR WHICH THE PATIENT RECEIVED TREATMENT WITH STEROID INJECTION. THE CAUSAL ROLE OF SYNVISC CANNOT BE EXCLUDED FOR THE OCCURENCE OF THE EVENT, HOWEVER THE LACK OF INFORMATION REGARDING THE UNDERLYING MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS USED BY THE PATIENT PRECLUDES THE COMPLETE CASE ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369657 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

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