BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 4959511 · Received July 30, 2015

    Report

    Report Number
    2246315-2015-98540
    Event Type
    Injury
    Date Received
    July 30, 2015
    Report Date
    July 24, 2015
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6) 2015; THIS CASE CONCERNS AN UNKNOWN PATIENT WHO EXPERIENCED UNSPECIFIED INFECTION IN UNSPECIFIED KNEE AFTER RECEIVING SYNVISC INJECTION. ALTHOUGH THE CASUAL ROLE OF THE DRUG CANNOT BE DENIED COMPLETELY FOR THE EVENT, HOWEVER, THE LACK OF INFO REGARDING DOES TO ONSET, LATENCY OF THE ONSET OF THE EVENT, PATIENTS MEDICAL HISTORY, CONCURRENT CONDITIONS, CONCOMITANT MEDICATION PRECLUDES A COMPREHENSIVE ASSESSMENT OF THIS CASE.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON 24-JUL-2015 FROM A PHYSICIAN. THIS CASE CONCERNS A PATIENT (DEMOGRAPHICS NOT PROVIDED) WHO DEVELOPED UNSPECIFIED INFECTION IN UNSPECIFIED KNEE AFTER RECEIVING SYNVISC INJECTION. NO PAST DRUGS, MEDICAL HISTORY, CONCOMITANT MEDICATION AND CONCURRENT CONDITIONS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT INITIATED TREATMENT WITH INTRA ARTICULAR SYNVISC INJECTION (DOSE, FREQUENCY, INDICATION, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED). ON AN UNSPECIFIED DATE, AFTER UNKNOWN LATENCY, PATIENT DEVELOPED MILD UNSPECIFIED INFECTION IN UNSPECIFIED KNEE AFTER RECEIVING SYNVISC INJECTION. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH 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. GENZYME 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. GENZYME BIOSURGERY WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 12-OCT-2015. THE PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 12-OCT-2015: FOLLOW UP INFORMATION RECEIVED DOES NOT CHANGES PREVIOUS CASE ASSESSMENT. SANOFI COMPANY COMMENT DATED 28-JUL-2015: THIS CASE CONCERNS AN UNKNOWN PATIENT WHO EXPERIENCED UNSPECIFIED INFECTION IN UNSPECIFIED KNEE AFTER RECEIVING SYNVISC INJECTION. ALTHOUGH, THE CAUSAL ROLE OF THE DRUG CANNOT BE DENIED COMPLETELY FOR THE EVENT, HOWEVER, THE LACK OF INFORMATION REGARDING DOSE TO ONSET, LATENCY OF THE ONSET OF THE EVENT, PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITIONS, CONCOMITANT MEDICATION PRECLUDES A COMPREHENSIVE ASSESSMENT OF THIS CASE.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2015 FROM A PHYSICIAN. THIS CASE CONCERNS A PATIENT; DEMOGRAPHICS NOT PROVIDED, WHO DEVELOPED UNSPECIFIED INFECTION IN UNSPECIFIED KNEE AFTER RECEIVING SYNVISC INJECTION. NO PAST DRUG, MEDICAL HISTORY OR CONCOMITANT MEDICATION AND CONCURRENT CONDITIONS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT INITIATED TREATMENT W/INTRA-ARTICULAR SYNVISC INJECTION (DOSE FREQUENCY, INDICATION, BATCH/LOT NUMBER AND EXPIRATION DATE; NOT PROVIDED). ON AN UNSPECIFIED DATE, AFTER UNKNOWN LATENCY, PATIENT DEVELOPED MILD UNSPECIFIED INFECTION IN UNSPECIFIED KNEE AFTER RECEIVING SYNVISC INJECTION. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED, OUTCOME: UNKNOWN, SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495869 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PREV MEDS=UNK