BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2223062 · Received July 20, 2011

    Report

    Report Number
    2244564-2011-00092
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BIO-TECHNOLOGY GEN (ISRAEL) LTD
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY CAUSALITY: POSSIBLY RELATED BASED ON THE INFO PROVIDED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    THIS SERIOUS REPORT WAS FROM A PHARMACIST IN THE USA. THE PT, A (B)(6), FEMALE, (B)(6), RECEIVED EUFLEXXA (1% SODIUM HYALURONATE) AND EXPERIENCED HEADACHE AND HEART PALPITATIONS. ON (B)(6) 2011, THE PT RECEIVED HER FIRST EUFLEXXA INJECTION AND AFTER THE INJECTION SHE REPORTED HEADACHE AND HEART PALPITATIONS. ON (B)(6) 2011, THE PT WENT TO THE HOSP AND WAS SEEN IN THE EMERGENCY ROOM (ER) WITH TACHYCARDIA AND HEART RATE 120 - 130 AND HEADACHE. THE PHARMACIST ADVISED THE PT WAS GIVEN A LOVENOX (ENOXAPARIN) INJECTION AND WAS ADMITTED FOR OBSERVATION. THE PT'S INITIAL VITAL SIGNS WERE TEMPERATURE WAS 98.3, HEART RATE WAS 146, RESPIRATIONS WERE 18 AND BLOOD PRESSURE WAS 134/73. AT THE TIME OF THE REPORT, THE STATUS OF THE EVENTS WERE UNK AND THE PT REMAINED HOSPITALIZED ON LOVENOX, 90 MG EVERY 12 HOURS. EUFLEXXA WAS DISCONTINUED. CONCOMITANT MEDICATIONS WERE REPORTED. MEDICAL HISTORY WAS REPORTED AND ALSO INCLUDED THE PT DENIED SMOKING AND ALCOHOL USE HISTORY AS WELL AS DENIED HISTORY OF HEPATIC OR RENAL DYSFUNCTION. FURTHER INFO HAS BEEN REQUESTED. IF NEW SIGNIFICANT INFO IS RECEIVED THE CASE WILL BE RE-EVALUATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization KCL| NORVASC ZYRTEC| LOVENOX| LASIX| CYTOTEC| TAMOXIFEN| DICOFENAC