BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 6121181 · Received November 22, 2016

    Report

    Report Number
    3000164186-2016-00023
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 11, 2016
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
    Product Code
    MOZ
    PMA / PMN Number
    P010029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PLATELET COUNT WAS DANGEROUSLY LOW (THROMBOCYTOPENIA). [THROMBOCYTOPENIA]. THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER IN UNITED STATES. THIS REPORT CONCERNS A (B)(6) YEAR OLD FEMALE WHO EXPERIENCED PLATELET COUNT WAS DANGEROUSLY LOW (THROMBOCYTOPENIA). DURING TREATMENT WITH INTRA-ARTICULAR EUFLEXXA (SODIUM HYALURONATE) SOLUTION FOR INJECTION 1 %, WEEKLY, FOR OSTEOARTHRITIS FROM (B)(6) 2016. ON (B)(6) 2016, THE PATIENT EXPERIENCED PLATELET COUNT WAS DANGEROUSLY LOW (THROMBOCYTOPENIA). THE PLATELET COUNT WAS DANGEROUSLY LOW (THROMBOCYTOPENIA) WAS MEDICALLY SIGNIFICANT. THE PATIENT REPORTED SEEING A HEMATOLOGIST ON (B)(6) 2016 AND WILL CONTINUE TO FOLLOW UP. ACTION TAKEN WITH EUFLEXXA WAS DOSE NOT CHANGED. ON AN UNKNOWN DATE, THE OUTCOME OF PLATELET COUNT WAS DANGEROUSLY LOW (THROMBOCYTOPENIA). WAS NOT RECOVERED. THE FOLLOWING CONCOMITANT MEDICATION WAS REPORTED: ATORVASTATIN (FROM AN UNKNOWN START DATE TO AN UNKNOWN STOP DATE). THE FOLLOWING LABORATORY VALUES WERE RELEVANT: BLOOD TEST: 28 MCL (NO ASSESSMENT), (B)(6) 2016. AT THE TIME OF REPORTING, THE CASE OUTCOME WAS NOT RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 16-NOV-2016. THE PATIENT CLARIFIED THE DATES OF HER EUFLEXXA INJECTIONS AND PROVIDED THE VALUE FOR THE REPORTED LOW PLATELET COUNT. OVERALL LISTEDNESS (CORE LABEL) IS UNLISTED. REPORTER CAUSALITY: RELATED. COMPANY CAUSALITY: UNASSESSABLE. 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770550 EUFLEXXA 1% SODIUM HYALURONATE MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other ATORVASTATIN (ATORVASTATIN)