BEUDAMED
    FDA Adverse Event Summary report: N

    EUFLEXXA

    MDR report key: 2867743 · Received December 7, 2012

    Report

    Report Number
    3000164186-2012-00212
    Date Received
    December 7, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT OR PROBLEM: THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED FROM A PATIENT IN THE UNITED STATES. THE PATIENT, A (B)(6) FEMALE WITH HISTORY OF HYPERTENSION, EXPERIENCED ELEVATED BLOOD PRESSURE AFTER RECEIVING ALL THREE EUFLEXXA (1% SODIUM HYALURONATE) INJECTIONS TO HER LEFT KNEE FOR OSTEOARTHRITIS OF THE LEFT KNEE. ON UNSPECIFIED DATES IN (B)(6) 2012, THE PATIENT RECEIVED ALL THREE EUFLEXXA INJECTIONS TO HER LEFT KNEE FOR OSTEOARTHRITIS OF THE LEFT KNEE. THE PATIENT STARTED MONITORING HER BLOOD PRESSURE AND NOTICED THAT HER BLOOD PRESSURE WAS ELEVATED. ON (B)(6) 2012, THE PATIENT'S BLOOD PRESSURE WAS 171/102 AND 180/107. ON (B)(6) 2012, THE PATIENT'S BLOOD PRESSURE WAS 152/98. THE PATIENT NOTED THAT SHE HAD NOT BEEN FEELING BAD (DETAILS UNSPECIFIED). THE PATIENT PLANNED TO CONTACT HER PHYSICIAN REGARDING THE ELEVATION IN BLOOD PRESSURE. FURTHER INFORMATION WAS NOT PROVIDED. MEDICAL HISTORY WAS PROVIDED INCLUDING A HISTORY OR HYPERTENSION. CONCOMITANT MEDICATIONS WERE PROVIDED. FURTHER INFORMATION HAS BEEN REQUESTED. IF NEW SIGNIFICANT INFORMATION IS RECEIVED, A RE-EVALUATION OF THE CASE WILL BE PERFORMED. COMPANY COMMENTS: PATIENT WITH H/O OF HTN ON MEDICATION STARTED MONITORING HER BP AND NOTED ELEVATED BP, NO OTHER SYMPTOMS, WEEKS AFTER EUFLEXXA INJECTION. UNCLEAR WHEN THE ELEVATED BP STARTED; UNASSESSABLE.

    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 54 YR Other DIOVAN| DAILY MULTIVITAMIN| EFFEXOR| GLUCOSAMINE