BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 670697 · Received February 3, 2006

    Report

    Report Number
    9610200-2006-00005
    Event Type
    Injury
    Date Received
    February 3, 2006
    Date of Event
    October 22, 2005
    Report Date
    February 3, 2006
    Manufacturer
    FIDIA FARMACEUTIC S.P.A
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS SERIOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF ARTHRITIS IN A FEMALE PT WHO WAS TREATED WITH HYALGAN 20MG/2ML FOR GONARTHROSIS. ABOUT NINE MONTHS LATER, THE PT RECEIVED A TREATMENT WITH HYALGAN IN THE KNEE AND THE SAME DAY SHE WAS FOUND TO HAVE PSEUDOSEPTIC ARTHRITIS, REDNESS, WARMTH, IMPOTENCE OF THE JOINT, AND FEVER WHICH LASTED 2 DAYS. ARTICULAR FLUID WAS PUS-LIKE CONATINED MANY POLYNUCLEAR CELLS, BUT BACTERIOLOGICAL RESEARCH WAS NEGATIVE. SEDIMENTATION RATE=123/125, WBC = 11700, CRP = 30,8 MG/L. THIS PT PAST MEDICAL HISTORY INCLUDES THYROIDECTOMY, DIFFUSE ARTHROSIS, RHEUMATOID ARTHRITIS SINCE 1997, ARTHRODESIS. THE PT WAS CONCOMITANTLY TREATED WITH CORTANCYL (PREDNISONE), METHOTREXATE (METHOTREXATE). THE PT HAS RECOVERED WITHIN 8 DAYS. METHOTREXATE WAS DISCONTINUED THEN A RECHALLENGE WAS PERFORMED WITH THIS DRUG, WHICH WAS NEGATIVE, ACCORDING TO THE REPORTER. NO FURTHER DETAILS AVAILABLE. ADD'L INFO WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA ARTICULAR INJECTIONS MOZ FIDIA FARMACEUTIC S.P.A NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization