BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE

    MDR report key: 3913097 · Received June 30, 2014

    Report

    Report Number
    MW5037013
    Event Type
    Other
    Date Received
    June 30, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 27, 2014
    Product Code
    MOZ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED A SYNVISC ONE SHOT TO BOTH KNEES AND INSTANTLY HAD PAIN AND COULD NOT WALK OUT OF THE OFFICE, THINKING THIS WAS NORMAL, I MANAGED TO GET MY SELF HOME ONTO THE COUCH WHERE I COULD NOT WALK FOR 2 DAYS, FOR THE NEXT 2 WEEKS I COULD NOT STRAIGHTEN OUT MY KNEES THEN MY RIGHT KNEE WOULD NOT WORK. I CAN ONLY USE MY LEFT KNEE. MY RIGHT LEG NO LONGER WILL BEND. I WENT BACK TO THE DOCTOR AND HE SAID I SHOULD HAVE A CORTISONE SHOT AND I SHOULD BE FINE. I TRIED TO EXPLAIN THAT PRIOR TO THE SYNVISC SHOT I WAS PLAYING RACQUET BALL THREE TIMES A WEEK AND NO I'M USING A CANE. I HAVE CALLED THE MANUFACTURER OF THE PRODUCT AND THEY DID MENTION THAT SOME PEOPLE END UP WITH A GAIT DISTURBANCE, BUT THEY COULD NOT GIVE ME SOME SORT OF COURSE OF ACTION, BASICALLY GOOD LUCK. I AM HEADING TO A NEW DOCTOR AND HOPEFULLY HE CAN DO SOMETHING FOR ME. I HAVE BEEN ON MAY WEBSITES AND READ MAY BAD REVIEWS BUT CAN'T SEEM TO FIND ANY ANSWERS. SINCERELY (B)(6). DIAGNOSIS OR REASON FOR USE: ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378902 SYNVISC ONE INTRA-ARTICULAR HYULUROMIC ACID MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR