BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE

    MDR report key: 1970029 · Received December 1, 2010

    Report

    Report Number
    MW5019092
    Event Type
    Other
    Date Received
    December 1, 2010
    Date of Event
    January 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    GENZYME
    Product Code
    MOZ
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAD BOTH KNEES INJECTED WITH SYNVISC ONE. ONE KNEE BLEW UP HAD TO BE DRAINED AND GIVEN STEROID (DRAINED 2X) 50 CC + 40 CC. OTHER KNEE NOT INFLAMED. KNEE IS NOW UNUSABLE. I FELL ON STREET UNABLE TO WALK ANY DISTANCE. FACE SWELLED UP. DIZZY, UPPER RESPIRATORY ISSUE-SHORTNESS OF BREATH, LETHARGIC. PRIOR TO INJECTIONS, I WAS HEALTHY, ON NO MEDICATION AND EXERCISED EVERY DAY. I WALKED 6 MILES OR BIKED 10-20 MILES A DAY. NOW I CAN'T EVEN WALK 5 BLOCKS. KNEE IS UNSTABLE. (B)(4). OTHER MEDICATIONS: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE INJECTION MOZ GENZYME

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR