BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO

    MDR report key: 2580827 · Received May 17, 2012

    Report

    Report Number
    9612392-2012-00006
    Event Type
    Injury
    Date Received
    May 17, 2012
    Date of Event
    April 13, 2012
    Report Date
    April 26, 2012
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS INITIALLY RECEIVED AS NON-SERIOUS CASE ON (B)(4) 2012 AND ONE OF THE SIMILAR SIX CASES REPORTED FROM A SAME FACILITY. WE ARE NOW INVESTIGATING THIS CASE.

    Description of Event or Problem · 1

    ADVERSE EVENT: SWELLING OF THE RIGHT KNEE, PYREXIA. ON (B)(6) 2012, A (B)(6) MALE, PT, RECEIVED ARTZ DISPO INJECTION WITH XYLOCAINE TO THE RIGHT KNEE FOR OSTEOARTHRITIS. ON (B)(6) 2012, HE DEVELOPED SWELLING OF THE RIGHT KNEE AND PYREXIA. IRRIGATION WAS PERFORMED. HE WAS GIVEN ANTIBIOTICS AND GAMMA-GLOBULIN. HE WAS TRANSFERRED TO THE HOSPITAL (B)(6). THE INJECTION PHYSICIAN CONSIDERED THAT THE EVENT WAS HIGHLY LIKELY INFECTION, AND POSSIBLY RELATED TO THE ARTZ DISPO BECAUSE OF NO OTHER POSSIBILITY. HE STATED THE PT WAS UNDER SUSCEPTIBLE CONDITION TO INFECTION BECAUSE OF HIS COMPLICATED DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ DISPO ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORP. NA 1YD18P, 2AD16P, 2AD18P OR 2AD2

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O XYLOCAINE (LIDOCAINE)-IR: 2 CC