BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC HYLAN G-F 20

    MDR report key: 2171286 · Received July 14, 2011

    Report

    Report Number
    MW5021392
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 14, 2011
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FRIDAY, (B)(6) 2011, I RECEIVED SYNVISC HYLAN G-F 20 -LOT #Y1018, EXP. 2013 (B)(6) 2ML INJECTIONS BILATERALLY INTO MY KNEES. APPROXIMATELY 2 HOURS LATER, BOTH MY KNEES SUDDENLY STIFFENED AND I BEGAN TO EXPERIENCE VERY SHARP, SUDDEN PAINS IN BOTH KNEE CAPS. I COULD BARELY SUPPORT MY OWN WEIGHT, AND ONLY SHUFFLE ALONG. I WAS GROCERY SHOPPING AND HAD TO RETURN HOME. UPON ARRIVING HOME, I COULD NOT NEGOTIATE THE STAIRS UP TO MY APARTMENT; BUT, HAD TO SIT ON MY BOTTOM AND PULL MYSELF UP THE STAIRS WITH MY HANDS/ARMS. GOING TO THE BATHROOM WAS A CHALLENGE AS I COULD NOT BEND MY KNEES TO SIT DOWN. I HAD BRACE MY HANDS ON THE WALL AND SINK AND LOWER MYSELF ONTO THE TOILET BY SLIDING MY LEGS STRAIGHT OUT. SATURDAY, (B)(6) 2011 I WOKE WITH FLU-LIKE SYMPTOMS. I WAS CONFINED TO BED AS IT WAS TOO PAINFUL TO SUPPORT MY OWN WEIGHT. COULD NOT NEGOTIATE THE TOILET IN A NORMAL MANNER, AS NOTED ABOVE. SUNDAY, (B)(6) 2011, I WOKE AGAIN WITH FLU-LIKE SYMPTOMS, AND CYSTS HAD FORMED IN SWEAT GLANDS UNDER MY ARMS AND BREASTS. MY BODY BEGAN EXPRESSING A LIQUID SUBSTANCE OUT VIA THE CYSTS. I STILL COULD NOT SUPPORT MY OWN WEIGHT. MONDAY, (B)(6) 2011 - I COULD "SHUFFLE" ALONG SLOWLY WITH STRAIGHT LEGS, AND WITH VERY SHARP, SUDDEN PAINS IN BOTH KNEES. EVERYONE THAT SAW ME SAID, "YOU LOOK AWFUL, WHAT HAPPENED!" TUESDAY, (B)(6) - COULD NOT WALK WITH A NORMAL GAIT, BUT ONLY SHUFFLE SLOWLY. COULD NOT NEGOTIATE STAIRS, UP OR DOWN. THE FLU-LIKE SYMPTOMS PERSISTED FOR APPROXIMATELY 2 WEEKS. THE CYSTS TOOK 3 WEEKS AND 4 DAYS TO RESOLVE, AND THERE IS STILL SOME RESIDUAL AREAS ON MY SKIN TODAY. IT IS ALMOST 4 FULL WEEKS SINCE RECEIVING SYNVISC BILATERALLY AND MY KNEES ARE STIFFER (LESS FLEXIBLE) AND MORE PAINFUL THAN BEFORE RECEIVING SYNVISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 SYNVISC MOZ GENZYME BIOSURGERY Y1018

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention