BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 6140744 · Received December 2, 2016

    Report

    Report Number
    3000164186-2016-00033
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    November 15, 2016
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    BILATERAL DVT'S (DEEP VEIN THROMBOSIS). THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE IN UNITED STATES. THIS REPORT CONCERNS A (B)(6) FEMALE WHO EXPERIENCED BILATERAL DVT'S (DEEP VEIN THROMBOSIS) DURING TREATMENT WITH INTRA-ARTICULAR EUFLEXXA (SODIUM HYALURONATE) SOLUTION FOR INJECTION 1 %, WEEKLY, FOR OSTEOARTHRITIS FROM (B)(6) 2016 TO AN UNKNOWN STOP DATE. IT WAS REPORTED THAT THE FIRST EUFLEXXA INJECTION WAS GIVEN ON (B)(6) 2016 AND THE SECOND EUFLEXXA INJECTION WAS GIVEN ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT EXPERIENCED BILATERAL DVT'S (DEEP VEIN THROMBOSIS). ON (B)(6) 2016 THE PATIENT WENT TO THE EMERGENCY ROOM WITH PAIN WHERE SHE WAS DIAGNOSED WITH BILATERAL DVT'S (DEEP VEIN THROMBOSIS). THE BILATERAL DVT'S (DEEP VEIN THROMBOSIS) WERE MEDICALLY SIGNIFICANT. ACTION TAKEN WITH EUFLEXXA WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE OUTCOME OF BILATERAL DVT'S (DEEP VEIN THROMBOSIS) WAS NOT RECOVERED. THE FOLLOWING CONCOMITANT MEDICATION WAS REPORTED: VITAMINS (FROM AN UNKNOWN START DATE TO AN UNKNOWN STOP DATE), ASPIRIN (FROM AN UNKNOWN START DATE TO AN UNKNOWN STOP DATE), PREDNISONE (FROM AN UNKNOWN START DATE TO AN UNKNOWN STOP DATE). AT THE TIME OF REPORTING THE CASE OUTCOME WAS NOT RECOVERED. OVERALL LISTEDNESS (CORE LABEL) IS UNLISTED. REPORTER CAUSALITY: RELATED. COMPANY CAUSALITY: NOT RELATED. OTHER CASE NUMBERS: CASE NUMBER, OTHERS = (B)(4). THIS AE OCCURRED IN THE US AND CONCERNS THE MEDICAL DEVICE EUFLEXXA. PLEASE REPORT TO YOUR LOCAL HEALTH AUTHORITY IF REQUIRED BY LOCAL LAW. THIS AE IS NOT REPORTABLE IN EU BECAUSE IT DOES NOT MEET THE DEFINITION OF A MEDICAL DEVICE INCIDENT ACCORDING TO THE REQUIREMENTS OF THE MEDICAL DEVICE DIRECTIVE, BECAUSE IT DID NOT OCCUR IN A EU + EFTA COUNTRY AND DID NOT RESULT IN A CORRECTIVE ACTION BY THE MANUFACTURER NO CORRECTIVE ACTION WAS DONE BY THE MANUFACTURER OR REQUESTED BY REGULATORS. ARGUS NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792323 EUFLEXXA 1% SODIUM HYALURONATE MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other ASPIRIN (ACETYLSALICYLIC ACID)| PREDNISONE (PREDNISONE)| VITAMINS (ASCORBIC ACID, ERGOCALCIFEROL)