BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 3271406 · Received July 30, 2013

    Report

    Report Number
    9610200-2013-00007
    Event Type
    Injury
    Date Received
    July 30, 2013
    Manufacturer
    FIDIA FARMACEUTICI SPA
    Product Code
    MOZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2011, THE FDA GRANTED THE PERMISSION FOR THE MFR 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 MFR) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (THE IMPORTER). THE PRESENT MDR REPORT SATISFIES THE REPORTING OBLIGATIONS FOR BOTH COMPANIES. THE QUALITY ASSURANCE DEPARTMENT AT FIDIA FARMACEUTICI SPA - THE MFR - HAS PERFORMED A DEEP EVALUATION OF THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION RELATIVE TO THE INVOLVED BATCH. THIS EVALUATION INCLUDED A REVIEW OF THE PRODUCTION PROCESS, IN-PROCESS CONTROLS, STERILIZATION PRINT-OUT, BIOBURDEN RESULTS, RELEASE RESULTS AND THE EVALUATION OF THE QUALITY CHARACTERISTICS OF THE RAW MATERIALS AND COMPONENTS USED IN THE MANUFACTURE OF BATCH 140700. FROM THIS EVALUATION, NO ANOMALY WAS FOUND. THE BATCH IS CONSIDERED PERFECTLY IN COMPLIANCE WITH THE SPECIFICATIONS. MOREOVER, THE QUALITY ASSURANCE DEPARTMENT AT FIDIA HAS COMPLETED THE STERILITY TESTS ON THE RESERVE SAMPLES FOR THE BATCH 140700. SPECIFICALLY, THE REPETITION OF THE STERILITY TESTS ON THE RESERVE SAMPLES, PERFORMED IN ACCORDANCE WITH THE AMERICAN PHARMACOPOEIA HAS GIVEN CONFORM RESULTS TO THE SPECIFICATIONS (NO EVIDENCE OF PRODUCT CONTAMINATION).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355813 HYALGAN HYALURONIC ACID FOR INTRARTICULAR USE MOZ FIDIA FARMACEUTICI SPA

    Patients

    Seq Age Sex Outcome Treatment
    1