BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 9211715 · Received October 19, 2019

    Report

    Report Number
    2246315-2019-00247
    Event Type
    Injury
    Date Received
    October 19, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 27, 2019
    Manufacturer
    GENZYME CORPORATION(RIDGEFIELD)
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 23-SEP-2019: FOLLOW UP INFORMATION DOES NOT CHANGE PRIOR CASE ASSESSMENT. BASED ON THE AVAILABLE INFORMATION THE CAUSAL RELATIONSHIP BETWEEN THE EVENTS SEVERE SWELLING ALL THROUGHOUT LEG AND COULDN'T SLEEP, STAND OR WALK FOR A FEW DAYS CANNOT BE DENIED WITH THE SUSPECT SYNVISC. HOWEVER, THE INFORMATION REGARDING TECHNIQUE USED WHILE ADMINISTRATION OF INJECTION, MEDICAL HISTORY AND CONCURRENT CONDITION PRECLUDES THE FINAL CASE ASSESSMENT.

    Description of Event or Problem · 1

    COULDN'T SLEEP, STAND OR WALK FOR A FEW DAYS [DIFFICULTY SLEEPING], COULDN'T SLEEP, STAND OR WALK FOR A FEW DAYS [DIFFICULTY IN STANDING], SEVERE SWELLING ALL THROUGHOUT LEG [SWELLING OF LEGS], COULDN'T SLEEP, STAND OR WALK FOR A FEW DAYS [WALKING DIFFICULTY]. CASE NARRATIVE: THIS CASE IS CROSS-REFERENCED WITH CASE ID: (B)(4) (MULTIPLE DEVICES). INITIAL INFORMATION RECEIVED ON 17-SEP-2019 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM HEALTH AUTHORITIES OF UNITED STATES VIA PHARMACIST UNDER REFERENCE MW5089247. THIS CASE INVOLVES A MALE PATIENT OF UNKNOWN AGE WHO EXPERIENCED SEVERE SWELLING ALL THROUGHOUT LEG (LATENCY: UNKNOWN), COULDN'T SLEEP, STAND OR WALK FOR A FEW DAYS (LATENCY: UNKNOWN), COULDN'T SLEEP, STAND OR WALK FOR A FEW DAYS (LATENCY: UNKNOWN) WHILE HE WAS TREATED WITH HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC). THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. ON AN UNKNOWN DATE IN 2019, THE PATIENT RECEIVED INTRA-ARTICULAR INJECTION OF HYLAN G-F 20, SODIUM HYALURONATE AT DOSAGE 2ML, WEEKLY FREQUENCY THREE TIMES I.E. FOR THREE WEEKS (BATCH, INDICATION: UNKNOWN) (INFORMATION FOR BATCH NUMBER WAS REQUESTED). ON (B)(6) 2019, PATIENT EXPERIENCED SEVERE SWELLING THROUGHOUT LEG (LATENCY: UNKNOWN) AND COULDN'T SLEEP, STAND OR WALK FOR A FEW DAYS (LATENCY: UNKNOWN) AFTER THE INJECTION. THE EVENTS WERE ASSESSED AS SERIOUS AND WERE MEDICALLY SIGNIFICANT. THE PATIENT MENTIONED THAT HE DID NOT HAVE THESE ISSUES WITH SYNVISC ONE. ACTION TAKEN: NOT APPLICABLE. CORRECTIVE TREATMENT: NOT REPORTED FOR ALL EVENTS. OUTCOME: UNKNOWN FOR ALL EVENTS. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED ON 23-SEP-2019 FOR SYNVISC (LOT NUMBER UNKNOWN) 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 IS IDENTIFIED AND MITIGATED THROUGH THE NCR 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 WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. THE FINAL INVESTIGATION WAS COMPLETED ON 23-SEP-2019. ADDITIONAL INFORMATION WAS RECEIVED ON 23-SEP-2019 FROM GEMG. PTC RESULTS RECEIVED AND PROCESSED. GLOBAL PTC NUMBER ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005914 SYNVISC MOZ MOZ GENZYME CORPORATION(RIDGEFIELD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R