BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 3807412 · Received April 28, 2014

    Report

    Report Number
    9610200-2014-00007
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    October 1, 2007
    Report Date
    April 14, 2014
    Manufacturer
    FIDIA FARMACEUTICI SPA
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 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 (B)(4). AS A CONSEQUENCE, FIDIA FARMACEUTICI S.P.A. (THE MANUFACTURER) SHOULD SUBMIT REPORTABLE CASES ON BEHALF OF (B)(4) (THE IMPORTER). HOWEVER, SINCE THIS IS A NON-US CASE OF WHICH FIDIA FARMACEUTICI S.P.A. HAS BECOME AWARE IN ITS ROLE OF PRODUCT MANUFACTURER, (B)(4) DOES NOT HAVE ANY REPORTING OBLIGATION. FIDIA FARMACEUTICI SPA COMMENTS: THIS IS A SPONTANEOUS REPORT FROM A CONSUMER WHICH DID NOT RECEIVED MEDICAL CONFIRMATION. THE GYNECOLOGIST CONFIRMED THE SPONTANEOUS ABORTION, AS REPORTED BY THE PT, BUT NOT THAT THE OCCURRENCE CONSTITUTED AN ADVERSE EVENT FOR WHICH THERE WAS A SUSPICION OF DRUG CAUSALITY. THIS CASE LACKS SUFFICIENT CLINICAL INFO (E.G. PT'S DEMOGRAPHICS, COMPLETE DETAILS OF THE EVENT, THERAPY DATES AND DOSAGES OF HYALGAN, COMPLETE MEDICAL AND SOCIAL HISTORY, CONCOMITANT MEDICATIONS, LAB/DIAGNOSTIC RESULTS, ETC.) TO MAKE A COMPLETE MEDICAL AND CAUSAL ASSESSMENT. HOWEVER, BASED ON FIDIA'S KNOWLEDGE OF THE PRODUCT (ITS TOXICOLOGY, METABOLISM, PHARMACOKINETICS), THE ABORTION WAS UNLIKELY INDUCED BY HYALGAN. THIS IS THE FIRST CASE OF SPONTANEOUS ABORTION ASSOCIATED WITH THE PRODUCT IN OVER 25 YEAR POST-MARKETING EXPERIENCE WITH MORE THAN (B)(4) PTS TREATED WORLDWIDE. NO BATCH NUMBER WAS RECEIVED ON THIS COMPLAINT; THEREFORE, NO INVESTIGATION CAN BE CONDUCTED. NO FURTHER INFO IS EXPECTED FOR THIS CASE. CONCLUSION: NO INVESTIGATION/NO ASSESSMENT POSSIBLE. CASE STATUS: CLOSED.

    Description of Event or Problem · 1

    AS A RESULT OF THE SAFETY DATA RECONCILIATION PROCESS BETWEEN FIDIA FARMACEUTICI SPA AND ITS WORLDWIDE BUSINESS PARTNERS, 8 SERIOUS INDIVIDUAL CASE-SAFETY REPORTS REGARDING HYALGAN HAVE BEEN IDENTIFIED. ALL THESE CASES WERE RECORDED IN (B)(6) (EUROPE) BETWEEN 2005 AND 2013. ALL LEGAL REQUIREMENTS APPLICABLE TO MARKETING AUTHORIZATION HOLDERS IN THE EUROPEAN UNION COUNTRIES HAVE BEEN FULFILLED BY THE LOCAL LICENSEE. FIDIA IS REPORTING THESE CASES AS MANUFACTURER AND KEEPER OF THE GLOBAL SAFETY DATABASE FOR THE PRODUCT. CASE 4 OF 8. SPONTANEOUS REPORT, LOCAL REFERENCE # (B)(4). INITIAL INFO RECEIVED ON (B)(4) 2009 FROM THE CONSUMER. A (B)(6) YEAR-OLD FEMALE PT, WITH MEDICAL HISTORY OF GONARTHROSIS, RECEIVED HYALGAN SOLUTION FOR INJECTION (HYALURONIC ACID) FOR GONARTHROSIS IN (B)(6) 2007. IN (B)(6) 2007, SHE WAS PREGNANT AND IN (B)(6) 2007, SHE EXPERIENCED SPONTANEOUS ABORTION AT (B)(6) OF AMENORRHEA. AT THE TIME OF THE REPORT, SHE HAD NO INFO CONCERNING ANATOMOPATHOLOGIC ANALYSIS PERFORMED ON THE FOETUS. ACCORDING TO THE PT, THE SPONTANEOUS ABORTION WAS RELATED TO HYALGAN INTAKE. THE PT GAVE HER GYNECOLOGIST'S ADDRESS. THE GYNECOLOGIST WAS CONTACTED BY PHONE ON (B)(4) 2009, HE CONFIRMED THE SPONTANEOUS ABORTION. HYALGAN HAD BEEN PRESCRIBED BY THE PT'S GENERAL PHYSICIAN. FURTHER INFO HAS BEEN REQUESTED, IN PARTICULAR THE RESULTS OF THE FOETUS ANATOMOPATHOLOGIC ANALYSIS, BUT NOT OBTAINED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254406 HYALGAN HYALURONIC ACID FOR INTRAARTICULAR USE MOZ FIDIA FARMACEUTICI SPA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other