BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2833650 · Received November 5, 2012

    Report

    Report Number
    3000164186-2012-00191
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITTLE INFO REPORTED FOR THIS (B)(6) FEMALE WHO WAS HOSPITALIZED FOR HYPERTENSION (230/130) UNK TIME AFTER RECEIVING EUFLEXXA. THE REPORTING PHYSICIAN STATED A DEFINITE CAUSALITY. INSUFFICIENT INFO TO MAKE A PROPER CAUSALITY ASSESSMENT, HOWEVER, HYPERTENSION IS AN EXPECTED EVENT ACCORDING TO THE LABELING.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT OR PROBLEM: THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN IN THE UNITED STATES. A (B)(6) FEMALE PT EXPERIENCED HYPERTENSION (230/130) AFTER ADMINISTRATION WITH EUFLEXXA (1% SODIUM HYALURONATE) FOR UNK INDICATION. ON AN UNK DATE, THE PT RECEIVED HER FIRST EUFLEXXA INJECTION FOR AN UNK INDICATION. ON (B)(6) 2012, THE PT EXPERIENCED VOMITING AND HYPERTENSION (230/130) AND WAS HOSPITALIZED. THE PT WAS TREATED FOR HYPERTENSION (TREATMENT MEDICATION UNSPECIFIED) AND THE PT WAS STABILIZED HOWEVER HAD NOT RECOVERED. AT THE TIME OF REPORT, IT WAS UNK IF PT HAD RECOVERED FROM VOMITING. THE PHYSICIAN STATED THE HYPERTENSION WAS DEFINITELY RELATED TO EUFLEXXA. THE PHYSICIAN ALSO STATED HE HAD NEVER SEEN THIS BEFORE AS HE HAS USED EUFLEXXA IN THE PAST AND LOVES THIS PRODUCT. MEDICAL HISTORY WAS PROVIDED WHICH INCLUDED ALLERGIC TO STATIN MEDICATIONS AND YELLOW DYE. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. F/U INFO WAS REQUESTED. IF NEW SIGNIFICANT INFO IS RECEIVED A RE-EVAL OF THE CASE 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 71 YR Hospitalization