BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 7171724 · Received January 8, 2018

    Report

    Report Number
    2246315-2017-00410
    Event Type
    Injury
    Date Received
    January 8, 2018
    Date of Event
    August 31, 2017
    Report Date
    December 12, 2017
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THIS CASE WAS CROSS REFERENCE WITH CASE ID: (B)(4) (CLUSTER) THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 12-DEC-2017 FROM OTHER HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) YEARS OLD MALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER 2 DAYS PATIENT HAD SWELLING, STIFFNESS, JOINT PAIN AND JOINT WARMTH NO MEDICAL HISTORY, PAST DRUG, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WAS PROVIDED. ON (B)(6) 2017, PATIENT RECEIVED TREATMENT WITH INTRAARTICULAR SYNVISC ONE INJECTION (DOSE, FREQUENCY AND INDICATION: NOT REPORTED) IN RIGHT KNEE. ON (B)(6) 2017, AFTER 2 DAYS OF RECEIVING SYNVISC ONE INJECTION, PATIENT HAD SWELLING, STIFFNESS, JOINT PAIN AND WARMTH. TREATMENT WAS AN INJECTION OF STEROIDS 40 MG. THE PATIENT RETURNED AGAIN ON (B)(6) 2017, WITH SWELLING, STIFFNESS, AND JOINT PAIN. THEY NOTICED LESS SWELLING AND LESS WARMTH. CORRECTIVE TREATMENT: STEROIDS FOR ALL EVENTS OUTCOME: UNKNOWN FOR JOINT PAIN; RECOVERING FOR REST EVENTS A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4) THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT WAS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. SANOFI 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. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. SERIOUSNESS CRITERION: REQUIRED INTERVENTION FOR ALL EVENTS ADDITIONAL INFORMATION WAS RECEIVED ON 03-JAN-2018. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    THIS CASE WAS CROSS REFERENCE WITH CASE ID: (B)(4) (CLUSTER). THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2017 FROM OTHER HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) YEARS OLD MALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER 2 DAYS PATIENT HAD SWELLING, STIFFNESS, JOINT PAIN AND JOINT WARMTH. NO MEDICAL HISTORY, PAST DRUG, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WAS PROVIDED. ON (B)(6) 2017, PATIENT RECEIVED TREATMENT WITH INTRAARTICULAR SYNVISC ONE INJECTION (DOSE, FREQUENCY AND INDICATION: NOT REPORTED) IN RIGHT KNEE. ON (B)(6) 2017, AFTER 2 DAYS OF RECEIVING SYNVISC ONE INJECTION, PATIENT HAD SWELLING, STIFFNESS, JOINT PAIN AND WARMTH. TREATMENT WAS AN INJECTION OF STEROIDS 40 MG. THE PATIENT RETURNED AGAIN ON (B)(6) 2017, WITH SWELLING, STIFFNESS, AND JOINT PAIN. THEY NOTICED LESS SWELLING AND LESS WARMTH. CORRECTIVE TREATMENT: STEROIDS FOR ALL EVENTS OUTCOME: UNKNOWN FOR JOINT PAIN; RECOVERING FOR REST EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND PTC RESULTS WERE PENDING. SERIOUSNESS CRITERION: REQUIRED INTERVENTION FOR ALL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16546 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention