BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO (SUPARTZ)

    MDR report key: 376933 · Received February 19, 2002

    Report

    Report Number
    9612392-2002-00006
    Event Type
    Injury
    Date Received
    February 19, 2002
    Date of Event
    February 4, 2002
    Report Date
    February 19, 2002
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARTHRITIS. ON 8/2001 THE PT CAME TO THE HOSPITAL FOR PAIN OF BOTH KNEES. THE INTRA-ARTICULAR INJECTION INTO THE LEFT KNEE WAS STARTED IN FREQUENCY OF TWICE MONTHLY FOR DIAGNOSIS OF OSTEOARTHROSIS OF BOTH KNEES (THE RIGHT KNEE: MILD). ON 1/2002 THE INTRA-ARTICULAR INJECTION WAS PERFORMED TO THE LEFT KNEE AS BEFORE. THE FOLLOWING MONTH, PAIN OF THE LEFT KNEE WAS AGGRAVATED AND RETENTION OF SYNOVIAL FLUID WAS OBSERVED. 2 DAYS LATER THE PT WAS ADMITTED TO THE HOSPITAL FOR WALKING DIFFICULTY. INFLAMMATION WAS SUSPECTED IN TESTS AND THE CLINICAL COURSE IS NOW UNDER OBSERVATION. 5 DAYS LATER THE SYMPTOM WAS MITIGATED AND THE PT IS SCHEDULED TO BE DISCHARGED. THE REPORTING DOCTOR WAS NEGATIVE IN ADMITTING INFECTION FROM LABORATORY DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ DISPO (SUPARTZ) SODIUM HYALURONATE MOZ SEIKAGAKU CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization XYLOCAINE (LIDOCAINE HYDROCHLORIDE): UNK.