BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 6757423 · Received August 1, 2017

    Report

    Report Number
    2246315-2017-00115
    Event Type
    Injury
    Date Received
    August 1, 2017
    Report Date
    July 11, 2017
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS CROSS REFERENCED WITH (B)(4) AND (B)(4) (CLUSTER). THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2017 FROM THE PHYSICIAN. THIS CASE CONCERNS TWO PATIENTS (DEMOGRAPHICS UNSPECIFIED) WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER UNKNOWN LATENCIES THE PATIENTS HAD TYPICAL PSEUDO-SEPTIC ISSUES. NO RELEVANT MEDICAL HISTORY, PAST DRUGS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENTS RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION (DOSE, FREQUENCY, INDICATION, LOT NUMBER AND EXPIRATION DATE: NOT REPORTED). ON AN UNKNOWN DATE, AFTER UNKNOWN LATENCIES OF RECEIVING THE INJECTION PATIENTS EXPERIENCED TYPICAL PSEUDO-SEPTIC UNIQUE TO SYNVISC PRODUCTS WHERE PATIENTS HAD "SWOLLEN, HOT KNEES FOR A COUPLE OF DAYS" AFTER INJECTION. IT WAS REPORTED THAT THE PATIENTS WERE TREATED WITH ASPIRATION AND UNSPECIFIED STEROID. CORRECTIVE TREATMENT: ASPIRATION AND UNSPECIFIED STEROID. OUTCOME: UNKNOWN. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER 48714. 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 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. SERIOUSNESS CRITERION: REQUIRED INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2017. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    THIS CASE WAS CROSS REFERENCED WITH (B)(4). THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 11-JUL-2017 FROM THE PHYSICIAN. THIS CASE CONCERNS TWO PATIENTS (DEMOGRAPHICS UNSPECIFIED) WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER UNKNOWN LATENCIES THE PATIENTS HAD TYPICAL PSEUDO-SEPTIC ISSUES. NO RELEVANT MEDICAL HISTORY, PAST DRUGS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENTS RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION (DOSE, FREQUENCY, INDICATION, LOT NUMBER AND EXPIRATION DATE: NOT REPORTED). ON AN UNKNOWN DATE, AFTER UNKNOWN LATENCIES OF RECEIVING THE INJECTION PATIENTS EXPERIENCED TYPICAL PSEUDO-SEPTIC UNIQUE TO SYNVISC PRODUCTS WHERE PATIENTS HAD "SWOLLEN, HOT KNEES FOR A COUPLE OF DAYS" AFTER INJECTION. IT WAS REPORTED THAT THE PATIENTS WERE TREATED WITH ASPIRATION AND UNSPECIFIED STEROID. CORRECTIVE TREATMENT: ASPIRATION AND UNSPECIFIED STEROID. OUTCOME: UNKNOWN. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERION: REQUIRED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537253 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention