BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 6711932 · Received July 13, 2017

    Report

    Report Number
    3000164186-2017-00018
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 14, 2017
    Report Date
    July 31, 2017
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEMARTHROSIS [HAEMARTHROSIS]. THIS SERIOUS, SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIA A SALES REPRESENTATIVE IN UNITED STATES. THIS REPORT CONCERNS A (B)(6) FEMALE WHO EXPERIENCED HEMARTHROSIS DURING TREATMENT WITH INTRA-ARTICULAR EUFLEXXA (SODIUM HYALURONATE) SOLUTION FOR INJECTION (CONCENTRATION AND DOSE UNKNOWN), ONCE/SINGLE, FOR OSTEOARTHRITIS FROM (B)(6) 2017. THE PHYSICIAN REPORTED THAT THE PATIENT HAD EXPERIENCED HEMARTHROSIS ON (B)(6) 2017 AFTER RECEIVING HER FIRST EUFLEXXA INJECTION ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT DISCONTINUED THE EUFLEXXA INJECTIONS AND THE EVENT RECOVERED ON (B)(6) 2017. TREATMENT FOR THE EVENT WAS NOT PROVIDED. THE PHYSICIAN REPORTED THE CAUSALITY OF HEMARTHROSIS AS UNLIKELY RELATED TO EUFLEXXA. THE HEMARTHROSIS WAS MEDICALLY SIGNIFICANT. ACTION TAKEN WITH EUFLEXXA WAS DOSE WITHDRAWN. AT THE TIME OF THIS REPORT, THE OUTCOME OF HEMARTHROSIS WAS RECOVERED. MEDICAL HISTORY WAS NOT REPORTED. THE FOLLOWING CONCOMITANT MEDICATION WAS REPORTED: COUMADIN. AT THE TIME OF REPORTING THE CASE OUTCOME WAS RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 31-JUL-2017: FOLLOW UP 01- REMOVED CLASSIFICATION OF NON VALID SURVEILLANCE DUE TO PATIENT DEMOGRAPHICS REPORTED. PRODUCT INDICATION, START AND STOP DATE, ROUTE, ACTION TAKEN UPDATED. CONCOMITANT MEDICATION ADDED. EVENT START DATE, STOP DATE, AND OUTCOME UPDATED. NARRATIVE UPDATED. OVERALL LISTEDNESS (CORE LABEL) IS UNLISTED. REPORTER CAUSALITY: RELATED. COMPANY CAUSALITY: RELATED. OTHER CASE NUMBERS: CASE NUMBER, OTHERS = (B)(4). MW 3500A MFR. RPT. # = 3000164-2017-00015. MW 3500A MFR. RPT. # = 3000164-2017-00018 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 DID NOT OCCUR IN A EU + (B)(6) COUNTRY AND DID NOT RESULT IN A CORRECTIVE ACTION BY THE MANUFACTURER NO CORRECTIVE ACTION WAS DONE BY THE MANUFACTURER OR REQUESTED BY REGULATORS. (B)(4).

    Description of Event or Problem · 1

    HEMARTHROSIS [HAEMARTHROSIS]. THIS SERIOUS, SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIA A SALES REPRESENTATIVE IN UNITED STATES. THIS REPORT CONCERNS A PATIENT OF UNKNOWN AGE AND GENDER WHO EXPERIENCED HEMARTHROSIS DURING TREATMENT WITH EUFLEXXA (SODIUM HYALURONATE) SOLUTION FOR INJECTION UNKNOWN ROUTE OF ADMINISTRATION, CONCENTRATION, AND DOSE, FOR PRODUCT USED FOR UNKNOWN INDICATION FROM AN UNKNOWN START DATE TO AN UNKNOWN STOP DATE. THE REPORTER STATED THAT THE PATIENT HAD EXPERIENCED HEMARTHROSIS AFTER RECEIVING EUFLEXXA INJECTION. THE HEMARTHROSIS WAS MEDICALLY SIGNIFICANT. ACTION TAKEN WITH EUFLEXXA WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF HEMARTHROSIS WAS UNKNOWN. CONCOMITANT MEDICATION AND MEDICAL HISTORY WERE NOT REPORTED. AT THE TIME OF REPORTING THE CASE OUTCOME WAS UNKNOWN. OVERALL LISTEDNESS (CORE LABEL) IS UNLISTED. REPORTER CAUSALITY: RELATED. COMPANY CAUSALITY: 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 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
    490957 EUFLEXXA 1 % SODIUM HYALURONATE MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other