BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 8635183 · Received May 23, 2019

    Report

    Report Number
    9610200-2019-00006
    Event Type
    Injury
    Date Received
    May 23, 2019
    Report Date
    May 23, 2019
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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. THE CASE IS A SPONTANEOUS REPORT BY A PHYSICIAN (MEDICALLY CONFIRMED) RECEIVED BY FIDIA BUSINESS PARTNER IN (B)(6). A MALE PATIENT (AGE UNSPECIFIED), ON UNSPECIFIED DATA, WAS ADMINISTERED IN THE KNEE WITH A SINGLE DOSE OF 20MG/2ML OF HYALGAN SOLUTION FOR INJECTION BY INTRA-ARTICULAR ROUTE FOR THE TREATMENT OF GONARTHROSIS. AFTER UNSPECIFIED TIME THE PATIENT EXPERIENCED SEPTIC ARTHRITIS (JOINT PAIN ASSOCIATED WITH JOINT SWELLING AT INJECTION SITE CONFIRMED BY THE ANALYSIS OF SYNOVIAL FLUID). THE BATCH NUMBER IS NOT AVAILABLE AT THE MOMENT; SO, NO EVALUATION CAN BE PERFORMED TO FULLY EXCLUDE A DRUG ORIGIN OF THE SEPTIC ARTHRITIS. SEPTIC ARTHRITIS IS AN EVENT LISTED IN THE CCSI OF HYALGAN AND OFTEN RELATED TO THE INJECTION ITSELF IN CASE OF ABSENCE OF ASEPTIC PRECAUTIONS, RATHER THAN TO THE DRUG. HOWEVER, IN ABSENCE OF FURTHER INFORMATION THE CAUSAL RELATIONSHIP IS ASSESSED AS POSSIBLE. THE CASE HAS BEEN DEEMED SERIOUS DUE TO HOSPITALIZATION. THIS CASE COMES FROM THE COUNTRY (B)(6) IN WHICH HYALGAN IS CLASSIFIED A DRUG.

    Description of Event or Problem · 0

    THI IS A SPONTANEOUS REPORT RECEIVED THROUGH FIDIA BUSINESS PARTNER IN (B)(6). IT IS A MEDICALLY CONFIRMED CASE. INITIAL INFORMATION RECEIVED ON 24-APR-2019, FROM A RHEUMATOLOGIST DURING A SEMINAR. ON UNSPECIFIED DATE, A MALE PATIENT (AGE UNSPECIFIED), WITH NO SPECIFIED MEDICAL HISTORY, RECEIVED HYALGAN 20 MG/2 ML, SOLUTION FOR INJECTION (SODIUM HYALURONATE), IN THE KNEE BY INTRA-ARTICULAR ROUTE FOR GONARTHROSIS. AN UNSPECIFIED TIME AFTER THE INJECTION, THE PATIENT EXPERIENCED JOINT PAIN ASSOCIATED WITH JOINT SWELLING IN THE INJECTION SITE. THE PATIENT WAS IMMEDIATELY HOSPITALIZED. SEPTIC ARTHRITIS WAS DIAGNOSED. AS CORRECTIVE MEASURE, THE PATIENT FIRST RECEIVED INTRAVENOUSLY AMOXICILLINE THEN ORALLY (NO OTHER INFORMATION PROVIDED). AFTER AN UNSPECIFIED DATE, EVENT RESOLVED AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. ACCORDING TO THE REPORTING PHYSICIAN, THE SEPTIC ARTHRITIS WAS NOT RELATED TO HYALGAN BUT TO THE MEDICAL PROCEDURE ITSELF. AT THE TIME OF REPORTING, THE PATIENT HAD FULLY RECOVERED FROM ARTHRITIS SEPTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432164 HYALGAN HYALURONATE SODIUM MOZ FIDIA FARMACEUTICI S.P.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization