BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA 1% SODIUM HYALURONATE

    MDR report key: 7041028 · Received November 16, 2017

    Report

    Report Number
    MW5073407
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    November 8, 2017
    Report Date
    November 14, 2017
    Manufacturer
    FERRING PHARMACEUTICALS INC.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED MY LAST OF THREE WEEKLY INJECTIONS OF EUFLEXXA IN MY LEFT KNEE BEGINNING (B)(6) 2017 AND ENDING (B)(6) 2017. EACH INJECTION BROUGHT ON MULTIPLE NEGATIVE SIDE EFFECTS. THESE SIDE EFFECTS INCLUDED: IMMEDIATE SWELLING OF THE LEFT CALF MUSCLE. JOINT PAIN ON THE LEFT SIDE OF MY BODY, UP TO AND INCLUDING MY LEFT WRIST AND MUSCLE ACHE IN THE LEFT FOREARM. INABILITY TO WALK FOR 3-4 DAYS FOLLOWING EACH INJECTION DUE TO SEVERE KNEE PAIN. NAUSEA. FATIGUE AND FLU-LIKE SYMPTOMS. EXTREMELY RED FACE AND FACIAL PUFFINESS APPROX 15 MINUTES POST INJECTION. RACING / POUNDING HEARTBEAT APPROX 5-10 MINUTES POST INJECTION AND PERSISTING APPROX 1-2 HOURS. IN SUMMATION, THE INJECTIONS HAVE MADE ME ILL, AND HAVE REDUCED MY AMBULATORY CAPACITY. I DID INFORM MY PHYSICIAN AFTER THE FIRST INJECTION. I WAS NOT ADVISED TO DISCONTINUE THE SERIES OF INJECTIONS. NOW I AM ADVISED THAT DUE TO THE INJECTIONS, KNEE SURGERY CANNOT EVEN BE DISCUSSED FOR TWO AND ONE-HALF MONTHS TO THREE MONTHS DUE TO INCREASED RISK ON INFECTION BECAUSE OF THE INJECTIONS. I REMAIN TOTALLY DISABLED AND WILL NOT ALLOW MYSELF TO BE SUBJECT TO TREATMENT WITH EUFLEXXA, OR SIMILAR INJECTIONS IN FUTURE. THANK YOU FOR COLLECTING DATA ON THIS MEDICATION TYPE. DATES OF USE: (B)(6) 2017. "DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: YES, DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: YES. OSTEO ARTHRITIS LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815584 EUFLEXXA 1% SODIUM HYALURONATE EUFLEXXA 1% SODIUM HYALURONATE MOZ FERRING PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability