BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 6092757 · Received November 10, 2016

    Report

    Report Number
    2246315-2016-00168
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    September 22, 2016
    Report Date
    August 26, 2020
    Manufacturer
    GENZYME CORPORATION(RIDGEFIELD)
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SANOFI COMPANY COMMENT DATED 8-NOV-2016: THIS CASE CONCERNS A PATIENT WHO RECEIVED TREATMENT WITH SYNVISC FOR OSTEOARTHRITIS AND LATER EXPERIENCED FEVER, HEADACHE, SWEATS, CHILLS, BODY ACHES AND INJECTION SITE INFLAMMATION. THE CAUSAL ROLE OF SUSPECT IN OCCURRENCE OF THE EVENT CANNOT BE DENIED AS EVENTS OCCUR IN CLOSE PROXIMITY WITH THE SUSPECT PRODUCT START DATE AND WITH EACH INJECTION EVENTS HAVE BEEN REPORTED TO BECOME MORE SEVERE. FURTHERMORE PATIENT'S MEDICAL HISTORY, CONCURRENT ILLNESS, PAST AND CONCOMITANT MEDICATIONS WILL ASSIST IN COMPREHENSIVE ASSESSMENT OF THE CASE.

    Description of Event or Problem · 1

    SWEATS [SWEATING], BODY ACHES [GENERAL BODY PAIN], FEVER [FEVER], HEADACHE [HEADACHE], CHILLS [CHILLS], INJECTION SITE INFLAMMATION [INJECTION SITE INFLAMMATION], ([INJECTION SITE PAIN]). CASE NARRATIVE: CASE WAS INITIALLY SUBMITTED VIA SANOFI LEGACY DATABASE AND IS NOW BEING RE-DISTRIBUTED TO FDA AT THEIR REQUEST. THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 02-NOV-2016 FROM A PATIENT VIA HEALTH AUTHORITY OF UNITED STATES (USA-FDA WITH REGULATORY REFERENCE NUMBER: MW5065390). THIS CASE CONCERNS A PATIENT OF UNSPECIFIED DEMOGRAPHICS WHO RECEIVED TREATMENT WITH SYNVISC AND LATER AFTER UNKNOWN LATENCY EXPERIENCED FEVER, HEADACHE, SWEATS, CHILLS, BODY ACHES AND INJECTION SITE INFLAMMATION. NO PAST DRUG, MEDICAL HISTORY, OR CONCURRENT CONDITION WAS PROVIDED. THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED THYROID (ARMOUR THYROID) AND MULTI-VITAMIN. ON AN UNKNOWN DATE IN 2016, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION EVERY WEEK (DOSE, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) INTO THE RIGHT KNEE FOR OSTEOARTHRITIS. ON (B)(6) 2016, WITH EACH INJECTION THE PATIENT SUFFERED FROM FEVER, HEADACHE, EXTRAORDINARY PAIN AND INFLAMMATION AT THE INJECTION SITE, SWEATS, CHILLS AND BODY ACHES. IT WAS REPORTED THAT THE COURSE OF TREATMENT WAS 3 INJECTIONS WITH EACH INJECTION, THE SYMPTOMS BECAME MORE SEVERE. ON AN UNKNOWN DATE IN 2016, THE PATIENT STOPPED TAKING OR USING THE PRODUCT. CORRECTIVE TREATMENT: UNKNOWN FOR ALL THE EVENTS. OUTCOME: UNKNOWN FOR ALL THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND PTC RESULTS WERE PENDING. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT FOR ALL THE EVENTS. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 8-NOV-2016: THIS CASE CONCERNS A PATIENT WHO RECEIVED TREATMENT WITH SYNVISC FOR OSTEOARTHRITIS AND LATER EXPERIENCED FEVER, HEADACHE, SWEATS, CHILLS, BODY ACHES AND INJECTION SITE INFLAMMATION. THE CAUSAL ROLE OF SUSPECT IN OCCURRENCE OF THE EVENT CANNOT BE DENIED AS EVENTS OCCUR IN CLOSE PROXIMITY WITH THE SUSPECT PRODUCT START DATE AND WITH EACH INJECTION EVENTS HAVE BEEN REPORTED TO BECOME MORE SEVERE. FURTHERMORE PATIENT'S MEDICAL HISTORY, CONCURRENT ILLNESS, PAST AND CONCOMITANT MEDICATIONS WILL ASSIST IN COMPREHENSIVE ASSESSMENT OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746042 SYNVISC MOZ MOZ GENZYME CORPORATION(RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O