BEUDAMED
    FDA Adverse Event Summary report: N

    HYALGAN

    MDR report key: 3172390 · Received April 17, 2013

    Report

    Report Number
    9610200-2013-00003
    Date Received
    April 17, 2013
    Manufacturer
    FIDIA FARMACEUTICI SPA
    Product Code
    MOZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON 11/28/2011, THE FDA GRANTED THE PERMISSION FOR THE MFR, FIDIA (B)(4), TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA PHARMA USA, INC. AS A CONSEQUENCE, FIDIA (B)(4) (THE MFR) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. PHARMACOVIGILANCE COMMENTS: A CAUSE/EFFECT RELATIONSHIP BETWEEN ACUTE URTICARIA/HIVES AND HYALGAN CANNOT BE EXCLUDED. THE POSSIBILITY THAT ALLERGIC OR ALLERGIC-LIKE REACTIONS CAN RARELY OCCUR AFTER RECEIVING HYALGAN IS RECOGNIZED AND REPORTED IN THE PRODUCT LABELING. HOWEVER, URTICARIA ASSOCIATED WITH HYALGAN USUALLY LASTS 24-48 HOURS AND RESOLVED WITHOUT SEQUELAE. NO LONG LASTING CASES HAVE EVER BEEN REPORTED. NO CASES OF BABOON SYNDROME ASSOCIATED WITH HYALGAN HAVE EVER BEEN RECEIVED FROM ANY SOURCE SINCE 1987, WHEN THE PRODUCT WAS FIRST PUT ON THE MARKET. (B)(4). TO OUR KNOWLEDGE, NO SIMILAR CASES ASSOCIATED WITH HYALURONIC ACID ADMINISTRATION ARE REPORTED IN THE LITERATURE TO DATE. PHARMACOKINETIC STUDIES ON BOTH ANIMALS AND HUMANS HAVE DEMONSTRATED THAT EXOGENOUS CIRCULATING HYALURONIC ACID IS RAPIDLY AND EFFICIENTLY DEGRADED AND ELIMINATED WITHIN A FEW HOURS/DAYS. MEDICAL INVESTIGATIONS CONDUCTED BY THE LOCAL DISTRIBUTOR ON THE CASE HAS BROUGHT TO LIGHT SOME ADDITIONAL POINTS THAT INDICATED OTHER POTENTIAL CAUSES FOR THE PT'S ALLERGIC REACTION. THE PT TESTED POSITIVE FOR METHYLCHLOROISOTHIAZOLINONE WHICH IS USED AS A PRESERVATIVE FOUND IN COSMETICS, SHAMPOOS AND SKIN CARE PRODUCTS AMONG A LIST OF OTHER SUBSTANCES. IN THE MEDICAL ASSESSOR'S OPINION, THE PT ALREADY HAD AN UNDERLYING ALLERGY, INCLUDING ALLERGIES TO TETRACYCLINE AND PREDNISONE, THAT COULD HAVE BEEN TRIGGERED BY OTHER FACTORS, OTHER THAN THE HYALGAN, WHICH RESULTED IN THE RASH THAT WAS TREATED AND RESOLVED, BUT REOCCURRED AFTER THE 5TH INJECTION. THIS CHEMICAL IS FOUND IN A MYRIAD OF PRODUCTS AND MAY HAVE CONTRIBUTED TO HIS RASH.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167166 HYALGAN HYALURONIC ACID FOR INTRA-ARTICULAR USE MOZ FIDIA FARMACEUTICI SPA

    Patients

    Seq Age Sex Outcome Treatment
    1