BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 2135168 · Received June 15, 2011

    Report

    Report Number
    MW5021031
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    December 28, 2010
    Report Date
    June 15, 2011
    Manufacturer
    HYALGAN FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED HYALGAN INJECTIONS IN EACH KNEE BY DR (B)(6), MD AT (B)(6) CTR ON (B)(6)-2010; AND (B)(6)-2010. STARTED SWELLING ON (B)(6)-2010 IN THE KNEE, CALF, AND ANKLES. WENT TO THE VA ER ON (B)(6)-2011, DR (B)(6), MD STATED THAT I HAD A REACTION TO THE INJECTIONS AND PRESCRIBED FUROSEMIDE 10MG TAB FOR 4 DAYS, LOST 10 POUNDS OF FLUID OUT OF MY LEGS AND ANKLES IN THOSE FOUR -4- DAYS. MY PRIMARY CARE PHYSICIAN, DR (B)(6), MD STATED ON (B)(6)-2011 THAT I HAD WHAT IS CALLED A "DELAYED REACTION" AND HAVE POOR CIRCULATION AND PRESCRIBED ADDITIONAL FUROSEMIDE 10MG TAB. AS NEEDED ALONG WITH POTASSIUM CHLORIDE 8MEQ SA TAB. I HAVE HAD INCIDENTS OF LEG AND ANKLE SWELLING AND CRAMPS EVER SINCE THOSE INJECTIONS AND HAVE TO TAKE FUROSEMIDE TO GET RID OF THE SWELLING. PRIOR TO THE INJECTIONS, I HAD NOT HAD INCIDENTS OF WATER RETENTION NOR SWELLING NOR LEG CRAMPS LIKE THIS THAT I HAVE HAD SINCE THE INJECTIONS. NOR WAS I TOLD THAT I HAD POOR CIRCULATION UNTIL AFTER THE INJECTIONS. MFG FOR: SANOFI-AVENTIS U.S. LLC; (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN SODIUM HYALURONATE SOLUTION 2ML MOZ HYALGAN FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening