BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 702150 · Received April 20, 2006

    Report

    Report Number
    9610200-2006-00011
    Event Type
    Injury
    Date Received
    April 20, 2006
    Report Date
    April 20, 2006
    Manufacturer
    FIDIA FARMACEUTICI SPA
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS FRENCH SPONTANEOUS LITERATURE REPORT (CASE 1 OF 2) DESCRIBES THE OCCURANCE OF STAPHYLOCOCCUS AUREUS KNEE ARTHITIS IN PATIENT AHO RECIEVED INTRAARTICULAR INJECTIONS OF SODIUM HYALURONATE FOR AN UNSPECIFIED INDICATION.DETAILS OF THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED SEVERAL INTRAARTICULAR INJECTIONS OF SODIUM HYA;URONATE AND CORTICOSTEROIDS. ON AN UNSPECIFIED DATE, THE PATIENT WAS ADMITTED FOR STAPHYLOCOCCUS AUREUS KNEE ARTHRITIS.THE EVENT IS CONSIDERED MEDICALLY SIGNIFICANT.THE OUTCOME OF THE EVENT IS UNK. THE REPORTER DID NOT PROVIDE A CASUALITY ASSESSMENT.BY CONVENTION, SPONTANEOUS REPORTS ARE CONSIDERED TO HAVE IMPLIED CASUAL RELATIONSHIP.IN THE ARTICLE IT WAS STATED "FAULTLESS ASPECTIC TECHNIQUE IS ESSENTIAL WHEN ADMINISTERING HYALURONATE VISCOSSUPPLEMENTATICN." REPORT SOURCE:LITERATURE:JOURNAL:JOINTT BONE SPINE;AUTHORS: ALBERT C, BROCC O, GERARD D, ROUX C, BULLER-ZI;TITLE: SEPTIC KNEE ARTHRITIS AFTER INTRO-ARTICULAR HYALCRONATE INJECTION: TWO CASE REPORTS.VOLUME: 73, YEAR 2006, PAGES: 205-207

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O