BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 7762272 · Received August 7, 2018

    Report

    Report Number
    MW5078923
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    May 17, 2018
    Report Date
    August 7, 2018
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOR 8 YEARS CALLER RECEIVED BILATERAL SYNVISC ONE INJECTIONS EVERY 6 MONTHS. ON (B)(6) 2018, CALLER LEFT THE DR'S OFFICE AFTER RECEIVING INJECTION, "FEELING FUNNY". LATER THAT NIGHT, HE BEGAN TO FEEL HEAT, SWELLING, AND WEAKNESS IN BOTH LEGS. HE WAS UNABLE TO MOVE OR WALK; HIS WIFE GAVE HIM FLUIDS AND CALLED THE DR'S OFFICE IN THE MORNING TO REPORT SYMPTOMS. CALLER BEGAN TO FEEL BETTER 24 HRS LATER, HOWEVER HE STILL SUFFERS FROM MUSCLE PAIN, WEAKNESS, AND ACHING. AFTER SEEKING SECOND OPINIONS FROM SEVERAL DRS AND CONTACTING POISON CONTROL, CALLER WAS INFORMED NUMEROUS INJECTIONS OF SYNVISC IS CONTRAINDICATED DUE TO THE INCREASED PROBABILITY OF TOXIC REACTION WITH EACH INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601145 SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention