BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID

    MDR report key: 5772116 · Received July 6, 2016

    Report

    Report Number
    9610200-2016-00006
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    April 14, 2016
    Report Date
    July 6, 2016
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. NO BATCH NUMBER WAS RECEIVED ON THIS COMPLAINT; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED. THE COMPANY RECEIVED THIS CASE REPORT THROUGH (B)(4) ON 10-JUN-2016 ((B)(4)). IT SHOULD BE NOTED THAT THE REPORT DOES NOT REPORT ANY BRAND NAME. THE ADVERSE REACTION "PAIN IN KNEE" IS EXPECTED FOR HYALURONIC ACID. THE CASE HAS BEEN ASSESSED AS "SERIOUS" DUE TO THE MEDICAL IMPORTANT EVENT. FIDIA HAS CLASSIFIED THE CASE AS BEING "SERIOUS/EXPECTED". THE RELATIONSHIP BETWEEN HYALURONIC ACID AND THE EVENT WAS DEEMED AS BEING "PROBABLE". DEVICE WAS NOT AVAILABLE.

    Description of Event or Problem · 0

    A (B)(6) MALE PATIENT WAS TREATED, FOR A OSTEO ARTHRITIS KNEES, WITH HYALURONIC ACID SOLUTION FOR INJECTION (HYALURONATE SODIUM), AT A UNKNOWN DOSAGE, BY PARENTERAL ROUTE, ON (B)(6) 2016. ON THE SAME DAY, FOLLOWING THE ADMINISTRATION OF THE DRUG, THE PATIENT EXPERIENCED A PAIN IN THE KNEE. HYALURONIC ACID WAS WITHDRAWN. AT THE TIME OF THE REPORTING THE PATIENT WAS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426435 HYALURONIC ACID HYALURONIC ACID MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other