BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYN VISC

    MDR report key: 1894064 · Received November 2, 2010

    Report

    Report Number
    MW5018067
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    September 6, 2010
    Report Date
    November 2, 2010
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER 3RD INJECTION OF SYNVISC - MY LEG SWELLED, I COULDN'T STAND ON IT, I COULDN'T STRAIGHTEN OUT OR BEND, I WAS SCREAMING IN PAIN. I CALLED THE DR, HE TOLD ME TO COME TO OFFICE ON MONDAY. WHEN I CALLED TO GET IN, THE DR COMPUTER WERE DOWN AND THEY REFUSED TO MAKE APPT OR ALLOW ME TO EVEN COME TO THE OFFICE. I CALLED ANOTHER DR AND WAS SEEN IN 2 HOURS. I STILL COULDN'T WALK ON THE LEG OR STRAIGHTEN. I WAS GIVEN A CORTIZONE INJECTION AND TOLD IT WAS A RARE REACTION - PSEUDO BACTERIAL NECROTIC INFECTION. THE INJECTION DRS OFFICE WHEN I CALLED TO INFORM THEM STATED THEY NEVER HEARD OF IT AND THAT SYNVISC DOESN'T LIST AS A REACTION. I WAS NEVER WARNED OF THIS REACTION POSSIBILITY AND THE INJECTING DR DIDN'T TREAT IT. SHORTLY AFTERWARD MY HEART WENT INTO ATRIAL FIB AND MY HEART RATE WENT UP TO 130. I AM NOW ON RATE CONTROL MEDS. I THINK SYNVISC CAUSED THIS ATRIAL FIB DUE TO MY BODIES REACTION AND STRESS BOTH KNEES WERE INJECTED BUT ONLY LEFT LEG HAD REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYN VISC NONE MOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other