BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2940491 · Received January 29, 2013

    Report

    Report Number
    3000164186-2013-00013
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY COMMENTS: GLUCOSE INCREASED OVER BASELINE IN DIABETIC PT. ALTHOUGH NOT A KNOWN ADVERSE REACTION, SOME CASES OF INCREASED GLUCOSE HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THIS SERIOUS SPONTANEOUS DEVICE REPORT WAS REC'D FROM A CONSUMER IN THE UNITED STATES. A PT, A (B)(6) FEMALE EXPERIENCED BLOOD GLUCOSE INCREASE TO 400 AFTER SHE REC'D THE FIRST EUFLEXXA (1% SODIUM HYALURONATE) INJECTION FOR THIS SERIES IN THE RIGHT KNEE FOR OSTEOARTHRITIS. ON (B)(6) 2013, THE PT REC'D THE FIRST EUFLEXXA INJECTION FOR THIS SERIES IN THE RIGHT KNEE FOR OSTEOARTHRITIS. ON (B)(6) 2013, THE PT EXPERIENCED BLOOD GLUCOSE INCREASE TO 400 WHEN NORMALLY THE BLOOD GLUCOSE WAS IN THE 100 TO 130 RANGE. SHE DENIED ANY INFECTION AT THE INJECTION SITE AND DENIED ANY ALTERATION IN HER DIET. IT WAS UNK IF EUFLEXXA INJECTIONS CONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS ONGOING. MEDICAL HISTORY WAS PROVIDED AND INCLUDED THE PT OF EUFLEXXA INJECTIONS TWO YRS GO W/O INCIDENT AND HAD A ROUND OF EUFLEXXA INJECTION IN 2012. CONCOMITANT MEDICATIONS WERE PROVIDED. FURTHER INFO HAS BEEN REQUESTED. IF NEW SIGNIFICANT INFO IS REC'D, A F/U REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38761 EUFLEXXA 1% SODIUM HYALURONATE MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other HYDROCHLOROTHIAZIDE| ATENOLOL| ASPIRIN| LANTUS| NOVOLOG| CRESTOR| VITAMIN D SUPPORT