BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO (SUPARTZ)

    MDR report key: 376944 · Received February 19, 2002

    Report

    Report Number
    9612392-2002-00005
    Event Type
    Injury
    Date Received
    February 19, 2002
    Date of Event
    December 22, 2001
    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

    ON 12/2001 THE PT VISITED A NEIGHBORING CLINIC FOR PAIN OF THE RIGHT KNEE AND RECEIVED THE INJECTION OF ARTZ DISPO INTO THE KNEE. ELEVEN DAYS LATER, THE PT RECEIVED THE 2ND INJECTION ON THEIR 2ND VISIT TO THE CLINICAL. THE NEXT DAY, THERE WAS RAPID AGGRAVATION OF PAIN OF THE RIGHT KNEE AND THE PT WAS INTRODUCED TO THE HOSPITAL WHERE THE REPORTING PHYSICIAN BELONGS TO AND THEN HOSPITALIZED. SYNOVIAL FLUID WAS CULTURED AND THE RESULT (REPORTED 3 DAYS LATER) SHOWED THAT CHRYSEOBACTERIUM (F.) INDOLOGENES AMOUNT WAS 1+. AN ANTIBIOTIC WAS ADMINISTERED. ALTHOUGH AN INFLAMMATORY REACTION WAS OBSERVED AT THE TEST AFTER HOSPITALIZATION, THE PHYSICIAN IN CHARGE WAS NEGATIVE IN ADMITTING INFECTION OF THE KNEE FROM PHYSICAL FINDINGS. TWO DAYS LATER, THE PHYSICIAN INTRODUCED THE PT TO THE INTERNAL DEPARTMENT OF THE HOSPITAL. THE PT WAS EXAMINED THOROUGHLY THERE, BUT NO CLEAR CAUSE WAS FOUND. THE SYMPTOM WAS MITIGATED GRADUALLY THEREAFTER. PT WAS DISCHARGED IN 01/2002.

    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 87 YR Hospitalization TO 12/21/2001.| XYLOCAINE (LIDOCAINE HYDROCHLORIDE), 12/10/2001