BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2862200 · Received December 5, 2012

    Report

    Report Number
    3000164186-2012-00214
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PT, A (B)(6) MALE WITH DIABETES MELLITUS, EXPERIENCED BLOOD SUGAR INCREASED AS HIGH AS 500 AFTER RECEIVING THE EUFLEXXA (1% SODIUM HYALURONATE) INJECTIONS BILATERALLY FOR OSTEOARTHRITIS. ON (B)(6) 2012, THE PT, WITH HISTORY OF DIABETES MELLITUS TYPE II, RECEIVED THE FIRST EUFLEXXA INJECTION BILATERALLY FOR OSTEOARTHRITIS. ON (B)(6) 2012, THE PT EXPERIENCED BLOOD SUGAR INCREASE AS HIGH AS 500. ON (B)(6) 2012, THE PT RECEIVED THE SECOND INJECTION. ON (B)(6) 2012, THE PT'S BLOOD SUGAR ELEVATED AGAIN UP TO 500. ON (B)(6) 2012, THE PT RECEIVED THE THIRD EUFLEXXA INJECTION. ON (B)(6) 2012, THE PT'S BLOOD SUGAR INCREASED TO 400. ON THE DAYS THAT HIS BLOOD SUGAR LEVELS WERE ELEVATED, THE PT ADJUSTED THE INSULIN DOSAGE. ON (B)(6) 2012, THE PT'S BLOOD SUGAR LEVEL WAS BACK TO NORMAL RANGE OF 140 IN THE MORNING AND 138 IN THE AFTERNOON. MEDICAL HISTORY WAS PROVIDED AND INCLUDED THE PT'S NORMAL BLOOD SUGAR LEVELS IN THE RANGE OF 100 TO 150. CONCOMITANT MEDICATIONS WERE PROVIDED. FURTHER INFO HAS BEEN REQUESTED. IF NEW SIGNIFICANT DATA IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. COMPANY COMMENTS: PT WITH TYPE II DIABETES MELLITUS EXPERIENCED GRADE 3 ELEVATED BLOOD GLUCOSE AFTER HYALURONIC ACID INJECTIONS. EUFLEXXA IS NOT KNOWN TO CAUSE THIS EVENT, HOWEVER, APPEAR TO BE TEMPORALLY-RELATED TO INJECTIONS. CONCOMITANT MEDICATIONS (PREDNISONE AND CYMBALTA) MAY CAUSE ELEVATED GLUCOSE; HOWEVER, SUFFICIENT INFO NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other GLUCOSAMINE (TO UNK)| RAMIPRIL (TO UNK)| PRILOSEC/(B)(4) (TO UNK)| CLOPIDOGREL (TO UNK)| MENTAX (TO UNK)| FUROSEMIDE (TO UNK)| PREDNISONE (TO UNK)| AGGRENOX (TO UNK)| WELCHOL (TO UNK)| TYLENOL/(B)(4) (TO UNK)| ALEVE (TO UNK)| CYMBALTA (TO UNK)| LANTUS (TO CONTINUING)| HUMALOG (TO CONTINUING)| METOPROLOL (TO UNK)| LYRICA (TO UNK)| CARBIDOPA (TO UNK)