BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 2039514 · Received March 23, 2011

    Report

    Report Number
    9610200-2011-00003
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 14, 2011
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    P950027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUALITY ASSURANCE DEPT AT FIDIA 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 131700. FROM THIS EVALUATION, NO ANOMALY WAS FOUND AND THE LOT IS CONSIDERED PERFECTLY IN COMPLIANCE WITH THE SPECIFICATIONS. PHARMACOVIGILANCE COMMENT: THE REPORTED EVENT OF JOINT INFECTION MAY HAVE BEEN SECONDARY TO INJECTION SITE ADMINISTRATION. OF NOTE, PRECAUTION HAS BEEN INDICATED IN THE PRODUCT REFERENCE DOCUMENT REGARDING STRICT ASEPTIC ADMINISTRATION TECHNIQUE TO AVOID INFECTIONS IN THE INJECTION SITE.

    Description of Event or Problem · 1

    INITIAL AND ADD'L INFO WAS REC'D BY SANOFI-AVENTIS FROM A PHYSICIAN VIA A SALES REP AND OFFICE MGR ON (B)(6) 2011: A FEMALE PT REC'D HYALGAN INJECTION FOR KNEE PAIN ON (B)(6) 2011. AFTER THE INJECTION, SHE EXPERIENCED A REACTION WHICH INCLUDED SWELLING IN THE JOINT AND HAD TO HAVE THE KNEE DRAINED. THE PT HAD TO HAVE 1.5 CC OF FLUID REMOVED FROM THE JOINT AND ALSO REC'D A CORTICOSTEROID INJECTION TO TREAT INFLAMMATION IN THE JOINT. SHE WAS TREATED IN THE OFFICE AND THEN WENT HOME. THE PT HAD REC'D PREVIOUS SODIUM HYALURONATE INJECTIONS WITHOUT A PROBLEM. NO FURTHER RELEVANT INFO WAS REPORTED. ADD'L INFO WAS REC'D FROM THE OFFICE MGR ON (B)(6) 2011: A MICROBIOLOGY REPORT ON AN UNK DATE SHOWED (B)(6). TREATMENT MEASURES INCLUDED SURGERY ON THE KNEE WHICH INVOLVED OPENING THE JOINT UP AND DEBRIDING THE AREA TO REMOVE THE INFECTION AND INTRAVENOUS (IV) ANTIBIOTICS. AT THE TIME OF THE REPORT, THE PT WAS HOSPITALIZED BUT THE REPORTER THOUGHT SHE WOULD GO HOME ON (B)(6) 2011. NO FURTHER RELEVANT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A. 131700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization