BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 7640713 · Received June 27, 2018

    Report

    Report Number
    9610200-2018-00007
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    June 27, 2018
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011017 ON 28 NOVEMBER 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI S.P.A. TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA FARMACEUTICI S.P.A. AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA FARMACEUTICI S.P.A. (THE MANUFACTURER) IS SUBMITTING THIS REPORT EVEN ON BEHALF OF FIDIA PHARMA USA INC. (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. THE CASE CAME FROM EUDRAVIGILANCE (COUNTRY (B)(6) IN WHICH FIDIA IS MAH OF THE PRODUCT). THE PATIENT AFTER THE USE OF THE PRODUCT HYALGAN HAD: ARTHRITIS. THE CASE HAS BEEN DEEMED AS SERIOUS BY THE REPORTER DUE TO A MEDICAL IMPORTANT EVENT. THE CASE HAS BEEN DEEMED AS SERIOUS AND EXPECTED AS AN INFLAMMATORY REACTION ( AS PAIN, SWELLING/EFFUSION, HEAT AND REDDENING) IS DESCRIBED IN THE HYALGAN SMPC. THE CAUSALITY RELATIONSHIP HAS BEEN EVALUATED AS PROBABLE BY THE COMPANY. NO NEW SIGNAL ALERT HAS BEEN DETECTED. NO ADDITIONAL INFORMATION IS REQUIRED TO PERFORM THIS MEDICAL EVALUATION FROM THE PV PHYSICIAN.

    Description of Event or Problem · 0

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN, DOWNLOADED BY FIDIA FROM EUDRAVIGILANCE ON (B)(6) 2018 (AUTHORITY NUMBER: (B)(4)). IT IS A MEDICALLY CONFIRMED CASE. THIS IS NOT THE ORIGINAL NARRATIVE OF THE SENDER. A (B)(6) MALE PATIENT WAS TREATED WITH HYALGAN (SODIUM (HYALURONATE DE), BY INTRA-ARTICULAR ROUTE, AT THE DOSE OF 20 MG DAILY IN (B)(6) 2017, FOR OSTEOARTHRITIS KNEE. IN (B)(6) 2017, THE PATIENT EXPERIENCED ARTHRITIS. THE EVENT WAS REPORT AS SERIOUS DUE TO MEDICALLY IMPORTANT EVENT. HYALGAN WAS WITHDRAWN. THE EVENT WAS RESOLVED. REACTION AS DESCRIBED BY THE PRIMARY SOURCE: (B)(6). NO CONCOMITANT MEDICATION WAS REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485850 HYALGAN HYALURONATE SODIUM MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other