BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 5509965 · Received March 18, 2016

    Report

    Report Number
    2246315-2016-00048
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    December 23, 2015
    Report Date
    March 10, 2016
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 5RS1011Z AND EXPIRATION DATE: MAY-2018.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: 5RS1011Z AND EXPIRATION DATE: MAY-2018.

    Description of Event or Problem · 1

    THIS CASE IS CROSS REFERRED WITH CASES (B)(4) (CLUSTER). THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON 10-MAR-2016 FROM A PHYSICIAN. THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO INITIATED TREATMENT WITH SYNVISC INJECTION AND LATER AFTER 17 DAYS HAD DRUG INTOLERANCE. NO PAST DRUGS, MEDICAL HISTORY, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WERE REPORTED. ON (B)(6) 2015, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION (DOSE, FREQUENCY: NOT PROVIDED, BATCH/LOT NUMBER: R141041, 5RSA011Z AND EXPIRATION DATE- APR-2017 AND MAY-2018) FOR GONARTHROSIS. ON (B)(6) 2015, AFTER THIRD APPLICATION OF SYNVISC, PATIENT SUFFERED FROM DRUG INTOLERANCE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MASSIVE SWELLING AND THE TREATMENT WITH SYNVISC WAS STOPPED. IT WAS REPORTED THAT A PUNCTURE WAS PERFORMED AND INFECTION WAS EXCLUDED. SYNOVIA DIAGNOSTIC AND BACTERIOLOGY WAS WITHOUT FINDINGS. THE SAME DAY, ORAL APPLICATION OF CORTISONE WAS PERFORMED. CORRECTIVE TREATMENT: CORTISONE. OUTCOME: RECOVERED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION. PHARMACOVIGILANCE COMMENT: (B)(4) COMPANY COMMENT DATED 15-MAR-2016: THIS CASE CONCERNS A PATIENT WHO EXPERIENCED INTOLERANCE WITH SYNVISC WITH THE SYMPTOMS OF EFFUSION AND SWELLING IN KNEE. AS PER THE REPORTED INFORMATION THE CAUSAL ROLE OF THE PRODUCT CANNOT BE EXCLUDED FROM THE OCCURRENCE OF THE EVENTS SINCE THERE IS A POSITIVE TEMPORAL RELATIONSHIP. HOWEVER, THE KIND OF REACTIONS THE PATIENT EXPERIENCED AS PART OF THE DEVICE TOLERANCE ARE EXPECTED AFTER THE USE OF SYNVISC AND ARE WELL DOCUMENTED, HENCE, DOES NOT AFFECT THE BENEFIT/RISK PROFILE OF THE PRODUCT.

    Description of Event or Problem · 1

    (B)(4). THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6)-2016 FROM A PHYSICIAN. THIS CASE CONCERNS A (B)(6) YEARS OLD MALE PATIENT WHO INITIATED TREATMENT WITH SYNVISC INJECTION AND LATER AFTER 17 DAYS HAD DRUG INTOLERANCE. NO PAST DRUGS, MEDICAL HISTORY, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WERE REPORTED. ON (B)(6)-2015, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION (DOSE, FREQUENCY: NOT PROVIDED, BATCH/LOT NUMBER: R141041, 5RSA011Z AND EXPIRATION DATE- APR-2017 AND MAY-2018) FOR GONARTHROSIS. ON (B)(6)-2015, AFTER THIRD APPLICATION OF SYNVISC, PATIENT SUFFERED FROM DRUG INTOLERANCE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MASSIVE SWELLING AND THE TREATMENT WITH SYNVISC WAS STOPPED. IT WAS REPORTED THAT A PUNCTURE WAS PERFORMED AND INFECTION WAS EXCLUDED. SYNOVIA DIAGNOSTIC AND BACTERIOLOGY WAS WITHOUT FINDINGS. THE SAME DAY, ORAL APPLICATION OF CORTISONE WAS PERFORMED. CORRECTIVE TREATMENT: CORTISONE. OUTCOME: RECOVERED. (B)(4). THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER R14041 EXPIRATION DATE (04/2017) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. BASED ON THE LOT NUMBER BATCH RECORD REVIEW & LOT NUMBER FREQUENCY ANALYSIS FOR LOT NUMBER R14041 NO CAPA WAS REQUIRED. SANOFI GENZYME GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORED ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSED POSSIBLE ASSOCIATIONS WITH THEIR CORRESPONDING PRODUCT LOT, AS PART OF ROUTINE SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. (B)(4). SANOFI GENZYME WOULD CONTINUE TO MONITOR COMPLAINTS TO DETERMINE IF A CAPA WAS REQUIRED. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION. FOLLOW UP WAS RECEIVED ON 21-MAR-2016. THE TREATING PHYSICIAN WAS NOT ABLE TO DETERMINE WHICH BATCH HAD BEEN USED ON THE PATIENT, AS IT WAS NOT DOCUMENTED IN PATIENT'S FILE. THE GLOBAL PTC NUMBER WAS ADDED. ADDITIONAL INFORMATION WAS RECEIVED ON 28-MAR-2016. PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 28-MAR-2016: THE FOLLOW UP INFORMATION RECEIVED DOES NOT CHANGE THE OVERALL CASE ASSESSMENT. SANOFI COMPANY COMMENT DATED 15-MAR-2016: THIS CASE CONCERNS A PATIENT WHO EXPERIENCED INTOLERANCE WITH SYNVISC WITH THE SYMPTOMS OF EFFUSION AND SWELLING IN KNEE. AS PER THE REPORTED INFORMATION THE CAUSAL ROLE OF THE PRODUCT CANNOT BE EXCLUDED FROM THE OCCURRENCE OF THE EVENTS SINCE THERE IS A POSITIVE TEMPORAL RELATIONSHIP. HOWEVER, THE KIND OF REACTIONS THE PATIENT EXPERIENCED AS PART OF THE DEVICE TOLERANCE ARE EXPECTED AFTER THE USE OF SYNVISC AND ARE WELL DOCUMENTED, HENCE, DOES NOT AFFECT THE BENEFIT/RISK PROFILE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167090 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) R141041

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention