BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2833647 · Received November 5, 2012

    Report

    Report Number
    3000164186-2012-00200
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY COMMENTS: INCREASED BLOOD PRESSURE IS KNOWN ADVERSE REACTION; HOWEVER, IN THIS CASE MAY BE ALLERGIC IN NATURE. PROBABLY RELATED. F/U WILL BE REQUESTED.

    Description of Event or Problem · 1

    THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED FROM A PT'S DAUGHTER IN THE UNITED STATES. THE PT, A (B)(6) FEMALE (B)(6), EXPERIENCED A SPIKE IN BLOOD PRESSURE (240/149), FLU-LIKE SYMPTOMS, DIZZINESS, NAUSEA AND HEADACHE AFTER ADMINISTRATION OF THE SECOND EUFLEXXA (1% SODIUM HYALURONATE) INJECTION FOR UNK INDICATION. ON (B)(6) 2012, A PT'S DAUGHTER REPORTED HER MOTHER, WHILE IN THE PHYSICIAN'S OFFICE, EXPERIENCED AN EVENT ON (B)(6) 2012 WITH HER SECOND INJECTOR OF EUFLEXXA, RECEIVED ON THAT DAY. THE PT'S DAUGHTER REPORTED THAT HER MOTHER HAD HER INITIAL DOSE ON (B)(6) 2012. UPON RECEIVING THE SECOND DOSE, THE PT HAD AN IMMEDIATE ONSET OF FLU-LIKE SYMPTOMS, DIZZINESS, NAUSEA, HEADACHE (HA) AND A SPIKE IN HER BLOOD PRESSURE. THE PT DOES NOT HAVE A PAST HISTORY OF HIGH BLOOD PRESSURE. THE PT'S DAUGHTER REPORTED THAT THE BLOOD PRESSURE READING WAS 240/149 AND THE PHYSICIAN GAVE THE PT BENADRYL (UNK AMOUNT), WHICH HELPED. THE PT WAS TRANSPORTED TO THE ER 'JUST DOWN THE STREET' WHERE SHE RECEIVED EPINEPHRINE, MORE BENADRYL, MORPHINE FOR HER SEVERE HA AND BLOOD PRESSURE MEDICATION (UNK DRUG/DOSAGE) AND HAD A CT SCAN TO RULE OUT STROKE. THE PT WAS ADMITTED AND SUBSEQUENTLY DISCHARGED ON (B)(6) 2012. AT THE TIME OF THE REPORT, SHE WAS STILL EXPERIENCING BLOOD PRESSURE FLUCTUATIONS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS: PT HAD NO PREVIOUS ISSUES WITH BLOOD PRESSURE. SHE IS NEGATIVE FOR TOBACCO AND ALCOHOL USE. THE PT IS A (B)(6). THE ONLY MEDICATION SHE TAKES IS SYNTHROID 50MG TABS X 2 DAILY, FOR A TOTAL DOSE OF 100MG; THE 100MG TABS CONTAIN YELLOW DYE, TO WHICH SHE IS ALLERGIC. OTHER ALLERGIES REPORTED WERE: BACTRIM (HIVES), AUGMENTIN, (HIVES), CELEBREX AND STATINS CAUSED FLANK PAIN AND "LIVER PROBLEMS," IF NEW SIGNIFICANT INFO IS RECEIVED, RE-EVAL OF THE REPORT WILL BE PERFORMED.

    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 72 YR Hospitalization SYNTHROID