BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO (SUPARTZ)

    MDR report key: 376888 · Received February 19, 2002

    Report

    Report Number
    9612392-2002-00001
    Event Type
    Injury
    Date Received
    February 19, 2002
    Date of Event
    June 16, 2001
    Report Date
    February 18, 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: AS THE PATIENT HAD PAIN OF THE LEFT KNEE, ARTZ DISPO WAS INJECTED INTO THE LEFT IN 1998. AS THE PATIENT CAME TO COMPLAIN OF PAIN OF BOTH KNEES. THE INJECTION OF ARTZ DISPO INTO THE RIGHT KNEE WAS ALSO STARTED IN 1999. THEREAFTER, THE PATIENT RECEIVED THE INJECTION EVERY 2 WEEKS. IN 2001, THE PATIENT RECEIVED INJECTION OF ARTZ DISPO INTO BOTH KNEES AS USUAL. TWO DAYS LATER, PAIN OF THE RIGHT KNEE WAS INTENSIFIED SO MUCH THAT THE PATIENT RECEIVED MEDICAL EXAMINATION IN THE EMERGENCY ROOM OF THE HOSPITAL. THE FOLLOWING DAY, THE PATIENT RECEIVED THE MEDICAL EXAMINATION IN THE ORTHOPEDICS AND WAS HOSPITALIZED ON SUSPICION OF INFECTION. SYNOVIAL FLUID PUNCTURE WAS CONDUCTED (THE RESULT OF CULTURE OF THE SYNOVIAL FLUID WAS NEGATIVE [-]). ARTHROSCOPY SHOWED SYNOVIAL MEMBRANE PROLIFERATION, AND SYNOVECTOMY WAS CONDUCTED. THEREAFTER, THE SYMPTOM WAS MITIGATED GRADUALLY AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 2 MONTHS LATER.

    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 83 YR Hospitalization 2001.| XYLOCAINE(IDOCAINE HYDROCHLORIDE): 1999 TO