BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 2033543 · Received March 24, 2011

    Report

    Report Number
    2244564-2011-00037
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS SERIOUS SPONTANEOUS DEVICE REPORT WAS RECEIVED FROM A SALES REP VIA A PHYSICIAN IN THE UNITED STATES. THE PATIENT OF AN UNKNOWN AGE AND GENDER EXPERIENCED PSEUDOSEPTIC REACTION AFTER RECEIVING THE EUFLEXXA (1% SODIUM HYALURONATE) INJECTION FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT RECEIVED A EUFLEXXA INJECTION (NUMBER OF INJECTIONS UNKNOWN) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A PSEUDOSEPTIC REACTION, AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM TO WASH IT OUT. THE TYPE AND DURATION OF TREATMENT WAS NOT PROVIDED. EUFLEXXA WAS DISCONTINUED. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. FURTHER INFORMATION HAS BEEN REQUESTED. IF NEW SIGNIFICANT DATA IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 Other