BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 4001597 · Received July 23, 2014

    Report

    Report Number
    3000164186-2014-00128
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    September 1, 2013
    Report Date
    July 21, 2014
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT OR PROBLEM: THIS SERIOUS SPONTANEOUS DEVICE REPORT WAS RECEIVED FROM A CONSUMER IN THE UNITED STATES. THE PATIENT, A (B)(6) FEMALE EXPERIENCED A FALL RESULTING IN A TWEAKED BACK REQUIRING BACK SURGERY, BAD KNEE ABRASIONS, LEGS AND FEET WERE HEAVY IN 2013 AND 2014, AND FELT NO PAIN RELIEF AFTER RECEIVING THE SECOND SET OF THREE EUFLEXXA (1% SODIUM HYALURONATE) INJECTIONS IN BOTH KNEES FOR OSTEOARTHRITIS. LOT NUMBER: UNSPECIFIED. EXPIRATION DATE: UNSPECIFIED. ON (B)(6) 2013, THE PATIENT RECEIVED EUFLEXXA INJECTIONS ONE, TWO, AND THREE RESPECTIVELY. THE PATIENT STATED THAT EUFLEXXA WORKED GREAT. ON AN UNSPECIFIED DATE IN APPROXIMATELY (B)(6) 2013, THE PATIENT EXPERIENCED HEAVINESS IN HER LEGS AND FEET. APPROXIMATELY ONE MONTH LATER, (B)(6) 2013, THE EVENT RESOLVED. ON (B)(6) 2014, THE PATIENT RECEIVED INJECTION ONE, TWO, AND THREE RESPECTIVELY OF THE SECOND SERIES OF EUFLEXXA. RIGHT AFTER THE FIRST INJECTION ON (B)(6) 2014, THE PATIENT EXPERIENCED HEAVINESS IN HER LEGS AND FEET. ON AND UNSPECIFIED DATE IN (B)(6) 2014, THE PATIENT FELL DOWN GOING DOWN A SET OF CEMENT STEPS AND TWEAKED HER BACK. THE PATIENT FELL BECAUSE HER LEGS AND FEET WERE HEAVY. THE PATIENT EXPERIENCED BAD KNEE ABRASIONS. ON (B)(6) 2014, THE PATIENT HAD SURGERY ON HER BACK (LUMBAR THREE AND FOUR). THE PATIENT ALSO EXPERIENCED NO PAIN RELIEF AFTER THE SECOND SERIES OF EUFLEXXA. ALL OF THE EVENTS WERE RESOLVED EXCEPT FOR THE BAD KNEE ABRASIONS AND NO PAIN RELIEF. EUFLEXXA THERAPY WAS COMPLETED. MEDICAL HISTORY WAS PROVIDED. CONCOMITANT MEDICATIONS INCLUDED AN UNSPECIFIED MEDICATION FOR DEPRESSION, TAKEN ORALLY (DOSE UNSPECIFIED), AND AN UNSPECIFIED MEDICATION FOR ANXIETY, TAKEN ORALLY (DOSE UNSPECIFIED). ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432261 EUFLEXXA 1% SODIUM HYALURONATE MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other ALEVE