BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO

    MDR report key: 2519945 · Received April 4, 2012

    Report

    Report Number
    9612392-2012-00005
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 13, 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. WE ARE NOW INVESTIGATING THIS CASE.

    Description of Event or Problem · 1

    ADVERSE EVENT: ALLERGIC SYNOVITIS. ON (B)(6) 2012 - A (B)(6) MALE PT RECEIVED FIRST INJECTION OF ARTZ DISPO TO THE LEFT KNEE FOR LATERAL MENISCUS INJURY. ON (B)(6) 2012 - HE RECEIVED FOURTH OR FIFTH INJECTION OF ARTZ DISPO. ON (B)(6) 2012 - HE VISITED THE EMERGENCY DEPT. ON (B)(6) 2012 - HE WAS ADMITTED TO THE HOSP. HE RECEIVED INTRAVENOUSLY CEFAMEZIN (CEFAZOLIN) 4 G. ON (B)(6) 2012 - HE WAS DISCHARGED FROM THE HOSP. ON (B)(6) 2012 - HE RECOVERED AT THE OUTPATIENT VISIT. THE PHYSICIAN CONSIDERED THE EVENT WAS PROBABLY RELATED TO ARTZ DISPO. THE PHYSICIAN CONSIDERED THIS ADVERSE EVENT WAS ALLERGIC SYNOVITIS AND UNLIKELY TO BE INFECTION. HE DOESN'T SUSPECT PRODUCT'S QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ DISPO ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization