BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 8590246 · Received May 8, 2019

    Report

    Report Number
    2246315-2019-00141
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    February 6, 2019
    Report Date
    June 13, 2019
    Manufacturer
    GENZYME CORPORATION(RIDGEFIELD)
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    LIMITED MOBILITY OF KNEE [INJECTION SITE JOINT MOVEMENT IMPAIRMENT]. WATER RETENTION [INJECTION SITE EDEMA]. INJECTION SITE PAIN [INJECTION SITE JOINT PAIN]. SWELLING [INJECTION SITE JOINT SWELLING]. CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 22-APR-2019 FROM OTHER HEALTHCARE PROFESSIONAL REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM HEALTH AUTHORITIES OF UNITED STATES UNDER REFERENCE MW5085601. THIS CASE INVOLVES A PATIENT (DEMOGRAPHICS UNKNOWN) WHO EXPERIENCED LIMITED MOBILITY OF KNEE (LATENCY: UNKNOWN), WATER RETENTION (LATENCY: UNKNOWN), INJECTION SITE PAIN AND SWELLING (LATENCY: UNKNOWN), AFTER RECEIVING TREATMENT 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 THREE SERIES INTRA-ARTICULAR INJECTIONS OF HYLAN G-F 20, SODIUM HYALURONATE AT DOSAGE 2 ML FREQUENCY THREE TIMES (BATCH, INDICATION: UNKNOWN) AND COMPLETED THE TREATMENT ON AN UNKNOWN DATE IN 2019. INFORMATION ON BATCH NUMBER WAS REQUESTED. ON (B)(6) 2019, PATIENT EXPERIENCED INJECTION SITE REACTION WITH THE LAST DOSE OF HYLAN G-F 20, SODIUM HYALURONATE WHICH INCLUDED SWELLING (LATENCY: UNKNOWN), WATER RETENTION (LATENCY: UNKNOWN), INJECTION SITE PAIN (LATENCY: UNKNOWN) AND LIMITED MOBILITY OF KNEE (LATENCY: UNKNOWN). IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE THESE REACTIONS WITH PREVIOUS DOSES. CORRECTIVE TREATMENT: NOT REPORTED FOR ALL EVENTS. OUTCOME: UNKNOWN FOR ALL EVENTS. SERIOUSNESS CRITERION: MEDICALLY SIGNIFICANT FOR ALL EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED ON (B)(6) 2019 FOR SYNVISC 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. FINAL INVESTIGATION COMPLETE DATE WAS 06-JUN-2019 SANOFI WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 06-JUN-2019. GLOBAL PTC NUMBER AND RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    LIMITED MOBILITY OF KNEE [INJECTION SITE JOINT MOVEMENT IMPAIRMENT], WATER RETENTION [INJECTION SITE EDEMA], INJECTION SITE PAIN [INJECTION SITE JOINT PAIN], SWELLING [INJECTION SITE JOINT SWELLING]. CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 22-APR-2019 FROM OTHER HEALTHCARE PROFESSIONAL REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM HEALTH AUTHORITIES OF UNITED STATES UNDER REFERENCE MW5085601. THIS CASE INVOLVES A PATIENT (DEMOGRAPHICS UNKNOWN) WHO EXPERIENCED LIMITED MOBILITY OF KNEE (LATENCY: UNKNOWN), WATER RETENTION (LATENCY: UNKNOWN), INJECTION SITE PAIN AND SWELLING (LATENCY: UNKNOWN), AFTER RECEIVING TREATMENT 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 THREE SERIES INTRA-ARTICULAR INJECTIONS OF HYLAN G-F 20, SODIUM HYALURONATE AT DOSAGE 2 ML FREQUENCY THREE TIMES (BATCH, INDICATION: UNKNOWN) AND COMPLETED THE TREATMENT ON AN UNKNOWN DATE IN 2019. ON (B)(6) 2019, PATIENT EXPERIENCED INJECTION SITE REACTION WITH THE LAST DOSE OF HYLAN G-F 20, SODIUM HYALURONATE WHICH INCLUDED SWELLING (LATENCY: UNKNOWN), WATER RETENTION (LATENCY: UNKNOWN), INJECTION SITE PAIN (LATENCY: UNKNOWN) AND LIMITED MOBILITY OF KNEE (LATENCY: UNKNOWN). IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE THESE REACTIONS WITH PREVIOUS DOSES. CORRECTIVE TREATMENT: NOT REPORTED FOR ALL EVENTS. OUTCOME: UNKNOWN FOR ALL EVENTS. SERIOUSNESS CRITERION: MEDICALLY SIGNIFICANT FOR ALL EVENTS. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED WITH GLOBAL PTC (B)(4) AND RESULTS WERE PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386297 SYNVISC MOZ MOZ GENZYME CORPORATION(RIDGEFIELD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R