BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 3913284 · Received June 26, 2014

    Report

    Report Number
    MW5037033
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SANOFI - AVENTIS U.S. LLC
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAD SYNVISC ONE INJECTIONS FOR FIRST TIME IN BOTH KNEES ON (B)(6) 2014. BEGAN HAVING INFLAMMATORY REACTION THAT STARTED (B)(6) 2014 AND BECAME DEBILITATING (B)(6) 2014. REC'D EMERGENCY CARE AND 90CC FLUID DRAINED FROM BOTH KNEES (TOTAL) ON (B)(6) 2014. HAD TO USE A WALKER TO GO ANYWHERE ON (B)(6) 2014 (PROVIDED BY EMERGENCY ROOM). RX FOR PREDNISONE (10 DAYS) OF FLUID BEING REMOVED HELPED, BUT RECOVERY IS STILL ONGOING AS OF TODAY (B)(6) 2014. I WENT FROM A HEALTHY, VERY ACTIVE CYCLIST-RIDING 65 MILES/DAY ON A BIKE TO BEING CRIPPLED. HAD TEMPERATURE OF 100.9 ON (B)(6) 2014. EMERGENCY ROOM WAS WATCHING FOR "SEPTIC KNEE" - HORRIBLE EXPERIENCE. THIS WAS A POTENTIALLY LIFE THREATENING EVENT. I AM SO THANKFUL I CAN EVEN WALK AT THIS POINT. THIS WAS MY FIRST EMERGENCY ROOM VISIT EVER. I HAVE A HIGH TOLERANCE TO PAIN AND THIS CRIPPLED ME. HORRIBLE. QUANTITY: 1 INJECTION BOTH KNEES, FREQUENCY: 1ST TREATMENT, HOW WAS IT TAKEN OR USED: INJECTION. DATE THE PERSON FIRST STARTED TAKING: (B)(6) 2014. WHY WAS THE PERSON USING THE PRODUCT: LOOKING FOR RELIEF FROM MINOR KNEE PAIN ASSOCIATED WITH MILD OSTEOARTHRITIS. SEVERE INFLAMMATORY EVENT IN BOTH KNEES, FEVER, SWELLING, IMMOBILITY/DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373203 SYNVISC ONE SYNVISC ONE MOZ SANOFI - AVENTIS U.S. LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| S LEVOTHYROXINE 0.75 MG/1XDAY