BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 7435526 · Received April 17, 2018

    Report

    Report Number
    9610200-2018-00005
    Event Type
    Injury
    Date Received
    April 17, 2018
    Date of Event
    June 12, 2017
    Report Date
    April 17, 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 (B)(4) (COUNTRY (B)(6) IN WHICH FIDIA IS MAH OF THE PRODUCT). THE PATIENT AFTER THE USE OF THE PRODUCT HYALGAN HAD: INJECTION SITE ERUPTION AND HYPERTHERMIA. THE CASE HAS BEEN DEEMED AS SERIOUS BY THE REPORTER DUE TO HOSPITALIZATION. THE CASE HAS BEEN DEEMED AS SERIOUS/EXPECTED. FROM THE ANALYSIS OF THE DATA, IT EMERGES THAT THE PATIENT WAS TREATED ONE YEAR BEFORE THE START OF THE AES. THUS, THERE SHOULD BE NO TEMPORAL RELATIONSHIP BETWEEN THE HYALGAN ADMINISTRATION AND THE AES REPORTED. NO FOLLOW-UP INFORMATION CAN BE OBTAINED. HOWEVER, IT IS POSSIBLE THAT THE DATE REPORTED COULD BE A MISTAKE. ASSUMING THAT THE DATE OF ADMINISTRATION WAS (B)(6) 2017 INSTEAD OF (B)(6) 2016, THE COMPANY JUDGES THE CAUSALITY AS POSSIBLE AND, CONSERVATIVELY, THE CASE WILL BE NOTIFIED TO THE FDA. THE DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS IS A SPONTANEOUS REPORT REPORTED BY A PHYSICIAN AND DOWNLOADED BY FIDIA FROM (B)(4) 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) FEMALE PATIENT WAS TREATED WITH HYALGAN (SODIUM HYALURONATE), BY INTRA-ARTICULAR ROUTE, AT THE DOSE OF 1 DOSAGE FORM IN TOTAL, ON (B)(6) 2016, FOR OSTEOARTHROSIS. ON (B)(6) 2017, THE PATIENT EXPERIENCED HYPERTHERMIA AND, ON (B)(6) 2017, THE PATIENT EXPERIENCED INJECTION SITE ERUPTION. THE EVENTS WERE REPORTED AS SERIOUS DUE TO HOSPITALIZATION. HYALGAN WAS WITHDRAWN. THE EVENTS WERE RESOLVED. NO CONCOMITANT MEDICATION WAS REPORTED. IN FRANCE HYALGAN IS A MEDICINAL PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278573 HYALGAN HYALURONIC ACID MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization