BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 11257566 · Received February 1, 2021

    Report

    Report Number
    2246315-2021-00058
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    November 24, 1998
    Report Date
    June 9, 2021
    Manufacturer
    GENZYME CORPORATION(RIDGEFIELD)
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    INFECTION [INFECTION NOS] BECAME WEAK AND SHAKY [WEAKNESS] BECAME WEAK AND SHAKY [SHAKING] NAUSEA [NAUSEA] MUSCLE ACHING [MUSCLE ACHE] FELT RAPID HEART BEAT [HEART RATE INCREASED] SYNVISC 2 ML IN RIGHT KNEE INTRAARTICULAR AS 1ST INJECTION FOR R.A. (RHEUMATOID ARTHRITIS) [OFF LABEL USE OF DEVICE]. CASE NARRATIVE: BASED ON INFORMATION PREVIOUSLY RECEIVED, IN THE GENERAL TAB THE "SIGNIFICANT FOR DEVICE" CHECK BOX WAS TICKED. THIS CASE IS DELETED FOLLOWING AN INCORRECT WORLDWIDE ID. THE NEW CASE (B)(4) WILL BE SUBMITTED WITH THE SAME INFORMATION. INITIAL INFORMATION WAS RECEIVED ON 08-JAN-2021 REGARDING AN UNSOLICITED VALID SERIOUS CASE FROM A PHYSICIAN VIA HEALTH AUTHORITIES OF UNITED STATES UNDER REFERENCE MW5097840. THIS CASE INVOLVES AN ADULT PATIENT (GENDER: UNKNOWN) WHO EXPERIENCED INFECTION, BECAME WEAK AND SHAKY, NAUSEA, MUSCLE ACHING, FELT RAPID HEART BEAT AND AFTER RECEIVING HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC) 2 ML IN RIGHT KNEE INTRAARTICULAR AS 1ST INJECTION FOR R.A. (RHEUMATOID ARTHRITIS) (OFF LABEL USE OF DEVICE). THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S), FAMILY HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED SYNVISC (HYLAN G-F 20, SODIUM HYALURONATE) AT DOSE OF 2 ML IN RIGHT KNEE VIA INTRA-ARTICULAR ROUTE AS 1ST INJECTION FOR RHEUMATOID ARTHRITIS (CONSIDERED AS OFF LABEL USE OF DEVICE; LATENCY: SAME DAY) (LOT - J808, EXPIRATION DATE: 01-SEP-2000) (FREQUENCY: UNKNOWN). ON (B)(6) 1998, AFTER UNKNOWN LATENCY, THE PATIENT HAD INFECTION, BECAME WEAK (ASTHENIA) AND SHAKY (TREMOR), MUSCLE ACHING (MYALGIA) AND NAUSEA, ALSO FELT RAPID HEART BEAT (HEART RATE INCREASED) THAT LASTED APPROXIMATELY 30 HOURS THEN SUBSIDED. THE PATIENT HAD NO RASH AND LOCAL KNEE. THESE EVENTS WERE ASSESSED AS MEDICALLY SIGNIFICANT. FINAL DIAGNOSIS WAS FELT RAPID HEART BEAT, MUSCLE ACHING, NAUSEA, BECAME WEAK AND SHAKY, INFECTION AND SYNVISC 2 ML IN RIGHT KNEE INTRAARTICULAR AS 1ST INJECTION FOR R.A. (RHEUMATOID ARTHRITIS). ACTION TAKEN: NOT APPLICABLE FOR OFF LABEL USE OF DEVICE; UNKNOWN FOR REST ALL EVENTS IT WAS NOT REPORTED IF THE PATIENT RECEIVED A CORRECTIVE TREATMENT. THE PATIENT OUTCOME IS REPORTED AS RECOVERED FOR FELT RAPID HEART BEAT, NOT APPLICABLE FOR OFF LABEL USE OF DEVICE; UNKNOWN FOR REST ALL EVENTS PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER (B)(4) ON 08-JAN-2021 FOR PRODUCT. BATCH NUMBER; UNKNOWN DEVICE NOT RETURNED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA (CORRECTIVE AND PREVENTIVE ACTION) 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 (NON-CONFORMANCE REPORT) PROCESS. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORS ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSES 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 WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED FINAL INVESTIGATION COMPLETE DATE: 22-JAN-2021 AND REOPENED. FOLLOW UP INFORMATION WAS RECEIVED ON 11-JAN-2021. COMET ID NUMBER ADDED. NO SIGNIFICANT INFORMATION ADDED. ADDITIONAL INFORMATION WAS RECEIVED ON 22-JAN-2021 FROM HEALTHCARE PROFESSIONAL. GLOBAL PTC RESULTS ADDED. TEXT WAS AMENDED ACCORDINGLY. FOLLOW UP INFORMATION WAS RECEIVED ON 25-FEB-2021 FROM OTHER HEALTHCARE PROFESSIONAL. THE COMPLAINT (B)(4) WAS REOPENED DUE TO INCOMPLETE COMPLAINT INFORMATION. NO SIGNIFICANT INFORMATION WAS RECEIVED. FOLLOW UP INFORMATION WAS RECEIVED ON 24-MAR-2021 FROM OTHER HEALTHCARE PROFESSIONAL. THE COMPLAINT (B)(4) WERE REOPENED DUE TO INCOMPLETE COMPLAINT INFORMATION. NO SIGNIFICANT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    INFECTION [INFECTION NOS], BECAME WEAK AND SHAKY [WEAKNESS], BECAME WEAK AND SHAKY [SHAKING], NAUSEA [NAUSEA], MUSCLE ACHING [MUSCLE ACHE], FELT RAPID HEART BEAT [HEART RATE INCREASED], SYNVISC 2 ML IN RIGHT KNEE INTRAARTICULAR AS 1ST INJECTION FOR R.A. (RHEUMATOID ARTHRITIS) [OFF LABEL USE OF DEVICE]. CASE NARRATIVE: INITIAL INFORMATION WAS RECEIVED ON 08-JAN-2021 REGARDING AN UNSOLICITED VALID SERIOUS CASE FROM A PHYSICIAN VIA HEALTH AUTHORITIES OF UNITED STATES UNDER REFERENCE MW5097840. THIS CASE INVOLVES AN ADULT PATIENT (GENDER: UNKNOWN) WHO EXPERIENCED INFECTION, BECAME WEAK AND SHAKY, NAUSEA, MUSCLE ACHING, FELT RAPID HEART BEAT AND AFTER RECEIVING HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC) 2 ML IN RIGHT KNEE INTRAARTICULAR AS 1ST INJECTION FOR R.A. (RHEUMATOID ARTHRITIS) (OFF LABEL USE OF DEVICE). THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S), FAMILY HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED SYNVISC (HYLAN G-F 20, SODIUM HYALURONATE) AT DOSE OF 2 ML IN RIGHT KNEE VIA INTRA-ARTICULAR ROUTE AS 1ST INJECTION FOR RHEUMATOID ARTHRITIS (CONSIDERED AS OFF LABEL USE OF DEVICE; LATENCY: SAME DAY) (LOT - J808, EXPIRATION DATE: 01-SEP-2000) (FREQUENCY: UNKNOWN). ON (B)(6) 1998, AFTER UNKNOWN LATENCY, THE PATIENT HAD INFECTION, BECAME WEAK (ASTHENIA) AND SHAKY (TREMOR), MUSCLE ACHING (MYALGIA) AND NAUSEA, ALSO FELT RAPID HEART BEAT (HEART RATE INCREASED) THAT LASTED APPROXIMATELY 30 HOURS THEN SUBSIDED. THE PATIENT HAD NO RASH AND LOCAL KNEE. THESE EVENTS WERE ASSESSED AS MEDICALLY SIGNIFICANT. FINAL DIAGNOSIS WAS FELT RAPID HEART BEAT, MUSCLE ACHING, NAUSEA, BECAME WEAK AND SHAKY, INFECTION AND SYNVISC 2 ML IN RIGHT KNEE INTRAARTICULAR AS 1ST INJECTION FOR R.A. (RHEUMATOID ARTHRITIS). ACTION TAKEN: NOT APPLICABLE FOR OFF LABEL USE OF DEVICE; UNKNOWN FOR REST ALL EVENTS IT WAS NOT REPORTED IF THE PATIENT RECEIVED A CORRECTIVE TREATMENT. THE PATIENT OUTCOME IS REPORTED AS RECOVERED FOR FELT RAPID HEART BEAT, NOT APPLICABLE FOR OFF LABEL USE OF DEVICE; UNKNOWN FOR REST ALL EVENTS PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER (B)(4) ON 08-JAN-2021 FOR PRODUCT. BATCH NUMBER; UNKNOWN. DEVICE NOT RETURNED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA (CORRECTIVE AND PREVENTIVE ACTION) 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 (NON-CONFORMANCE REPORT) PROCESS. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORS ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSES 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 WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. FINAL INVESTIGATION COMPLETE DATE: 22-JAN-2021. FOLLOW UP INFORMATION WAS RECEIVED ON 11-JAN-2021. COMET ID NUMBER ADDED. NO SIGNIFICANT INFORMATION ADDED. ADDITIONAL INFORMATION WAS RECEIVED ON 22-JAN-2021 FROM HEALTHCARE PROFESSIONAL. GLOBAL PTC RESULTS ADDED. TEXT WAS AMENDED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156857 SYNVISC MOZ MOZ GENZYME CORPORATION(RIDGEFIELD) J808

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R