BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC

    MDR report key: 5429822 · Received February 11, 2016

    Report

    Report Number
    2246315-2016-00018
    Date Received
    February 11, 2016
    Report Date
    January 28, 2016
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2016 FROM A NON HEALTH CARE PROFESSIONAL. STUDY ID: SANOFI PATIENT CONNECTION THIS CASE CONCERNS AN ADULT FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC AND HAD SWELLING IN KNEE. NO PAST DRUG, MEDICAL HISTORY, CONCOMITANT MEDICATION OR CONCURRENT CONDITION WAS PROVIDED. ON (B)(6) 2014, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION AT A DOSE OF 2 ML (FREQUENCY, INDICATION, BATCH/LOT NUMBER, EXPIRATION DATE: NOT PROVIDED). ON AN UNKNOWN DATE, AFTER UNKNOWN LATENCY, PATIENT HAD SWELLING IN KNEE. PATIENT WENT TO EMERGENCY ROOM. PATIENT TOOK CORTISONE SHOTS AFTER WHICH SWELLING WENT DOWN. IT WAS REPORTED THAT PATIENT HAD SWELLING FOR 06 WEEKS AFTER GOING TO EMERGENCY ROOM. ACTION TAKEN: UNKNOWN. OUTCOME: RECOVERED. REPORTER CAUSALITY: UNKNOWN. COMPANY CAUSALITY: ASSOCIATED. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION.

    Description of Event or Problem · 1

    THIS SOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON 28-JAN-2016 FROM A NON HEALTH CARE PROFESSIONAL VIA A PATIENT SUPPORT PROGRAM. (B)(4). THIS CASE CONCERNS AN ADULT FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC AND HAD SWELLING IN KNEE. NO PAST DRUG, MEDICAL HISTORY, CONCOMITANT MEDICATION OR CONCURRENT CONDITION WAS PROVIDED. ON (B)(6) 2014, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION AT A DOSE OF 2 ML (FREQUENCY, INDICATION, BATCH/LOT NUMBER, EXPIRATION DATE: NOT PROVIDED). ON AN UNKNOWN DATE, AFTER UNKNOWN LATENCY, PATIENT HAD SWELLING IN KNEE. PATIENT WENT TO EMERGENCY ROOM. PATIENT TOOK CORTISONE SHOTS AFTER WHICH SWELLING WENT DOWN. IT WAS REPORTED THAT PATIENT HAD SWELLING FOR 06 WEEKS AFTER GOING TO EMERGENCY ROOM. ACTION TAKEN: UNKNOWN. OUTCOME: RECOVERED/ RESOLVED. 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 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. SANOFI GENZYME BIOSURGERY WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER CAUSALITY: UNKNOWN. COMPANY CAUSALITY: ASSOCIATED. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 10-FEB-2016. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89231 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention