BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 5652675 · Received May 13, 2016

    Report

    Report Number
    9610200-2016-00004
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    March 17, 2016
    Report Date
    May 13, 2016
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CASE COMES FROM THE (B)(6) (REF.NO. (B)(4)) AND IT WAS RECEIVED FROM LABORATORIOS FIDIA FARMACEUTICA S.L.U. (THE FIDIA'S PARTNER IN (B)(4)) ON 18 APRIL 2016. THE ADVERSE REACTIONS "INJECTION SITE JOINT PAIN AND INJECTION SITE EDEMA" ARE EXPECTED FOR HYALGAN. FIDIA ALSO CONSIDERED AN "OFF LABEL USE" BECAUSE THE HAND SITE IS NOT CONSIDERED IN THE SPC OF THE PRODUCT IN SPAIN. THE CASE HAS BEEN ASSESSED AS "SERIOUS" DUE TO THE MEDICAL IMPORTANT EVENT. FIDIA HAS CLASSIFIED THE CASE AS BEING "SERIOUS/UNEXPECTED". THE RELATIONSHIP BETWEEN HYALGAN AND THE EVENTS WAS DEEMED AS BEING "PROBABLE". DEVICE NOT AVAILABLE.

    Description of Event or Problem · 0

    (B)(6): ON (B)(6) 2016 A HYALURONIC ACID INFILTRATION WAS ADMINISTERED FOR RHIZARTHROSIS IN HER RIGHT HAND WITH 1 YEAR EVOLUTION. NO PREVIOUS INFILTRATIONS WITH HYALURONIC ACID. AFTER THE INFILTRATION SHE PRESENTS OEDEMA IN THE HAND AND PAIN BUT CONTROLLED, VAS: 5. ON (B)(6) 2016 SHE GOES TO A PAIN CLINIC OF A SPECIALITY CENTER BECAUSE SHE PRESENTS AN IMPORTANT OEDEMA THAT HAS INCREASED SINCE THE INFILTRATION, REDDENING AND VERY INTENSE PAIN SINCE THE DAY BEFORE IN THE AFTERNOON, VAS = 10. SHE DID NOT PRESENT AN INCREASE OF TEMPERATURE. IT IS PUT LOCAL COLD, IT WAS ADMINISTERED 50 MG DEXKETOPROFEN I.V., 1 G PARACETAMOL I.V AND 4 MG ONDANSETRON I.V. SYMPTOMS WERE IMPROVING AND OEDEMA AND PAIN DECREASED. CURRENT THERAPY: FENTANYL 50 MCG/72 H, MIRTAZAPINE, IBUPROFEN/8 H, DULOXETINE 60/24 H, DEPRELIO, PARACETAMOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307978 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other