BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 5517474 · Received March 22, 2016

    Report

    Report Number
    9610200-2016-00001
    Event Type
    Injury
    Date Received
    March 22, 2016
    Date of Event
    December 15, 2015
    Report Date
    March 22, 2016
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 ADVERSE REACTION "LEG INFECTION" IS EXPECTED FOR HYALGAN. THE REACTION HAS BEEN ASSESSED AS "SERIOUS" BECAUSE HAS BEEN CONSIDERED IMPORTANT FROM A MEDICAL POINT OF VIEW. FIDIA HAS CLASSIFIED THE CASE AS BEING "SERIOUS/EXPECTED". THE RELATIONSHIP BETWEEN HYALGAN AND THE EVENT IS DEEMED AS BEING "PROBABLE". "DIALYSIS" WAS NOT CONSIDERED AS AN ADVERSE EVENT. IT IS A TREATMENT FOR A PRE-EXISTING CONDITION. FOLLOW-UP INFORMATION HAS BEEN REQUIRED. THE CASE IS NOTIFYING LATE DUE TO THE TECHNICAL PROBLEMS DURING THE TEST PHASE FOR THE ELECTRONIC SUBMISSION AS WEBTRADER. DEVICE WAS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS SPONTANEOUS, SERIOUS ADVERSE EVENT WAS REPORTED BY A CLINICAL COORDINATOR AND CONCERNED AN (B)(6) MALE PATIENT. IN (B)(6) 2015 THE PATIENT WAS STARTED ON HYALGAN OF AN UNKNOWN DOSE, ONCE A WEEK FOR 5 WEEKS FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE THE PATIENT WAS STARTED ON DIALYSIS. IN (B)(6) 2015 THE PATIENT'S DIALYSIS PHYSICIAN DIAGNOSED THE PATIENT WITH AN INFECTION OF HIS LEG. THE PATIENT HAD RECEIVED 2 OUT OF THE 5 HYALGAN INJECTIONS PRIOR TO THE LEG INFECTION AND IT WAS UNKNOWN WHETHER THE PATIENT WOULD GET THE OTHER 3 INJECTIONS. THE LOT NUMBER AND EXPIRATION DATE WERE UNKNOWN. AS OF (B)(6) 2015 IT WAS UNKNOWN WHETHER THE PATIENT CONTINUED ON HYALGAN. THE OUTCOME OF DIALYSIS AND THE LEG INFECTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171460 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other