BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZAL

    MDR report key: 1694257 · Received May 18, 2010

    Report

    Report Number
    9612392-2010-00004
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    April 16, 2010
    Report Date
    May 18, 2010
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IMPLANTED: (B) (6) 2010, (B) (6) 2010. WE ARE NOW INVESTIGATING THIS CASE.

    Description of Event or Problem · 1

    ADVERSE EVENT: SEPTIC ARTHRITIS; KNEE PAIN; JOINT INFLAMMATION. ON (B) (6) 2010 - A (B) (6) FEMALE PT RECEIVED 1ST INJECTIONS OF SUPARTZ BILATERALLY FOR OSTEOARTHRITIS AND TOLERATED WELL. ON (B) (6) 2010 - SHE RECEIVED 2ND INJECTIONS OF SUPARTZ BILATERALLY AND TOLERATED WELL. ON (B) (6) 2010 - SHE RECEIVED 3RD INJECTIONS OF SUPARTZ BILATERALLY AND TOLERATED WELL. ON (B) (6) 2010 - SHE COMPLAINED OF INFLAMMATION AND PAIN TO HER RIGHT KNEE. ASPIRATIONS PERFORMED ON THE KNEE REFLECTED A THICK PURULENT SUBSTANCE WHICH INDICATED INFECTION. SHE WAS ADMITTED TO THE HOSPITAL TO HAVE AN ARTHROSCOPIC WASH. SHE WAS HOSPITALIZED 5 DAYS WITH ANTI-BIOTIC TREATMENTS. THE LAB RESULTS INDICATED RARE GRAM POSITIVE COCCI IN (B) (6); HOWEVER, TESTED NEGATIVE FOR CULTURES AT 24 HOURS AND 48 HOURS. ON (B) (6) 2010 - SHE WAS DISCHARGED FROM THE HOSPITAL. THE PHYSICIAN DOES RELATE THE INCIDENT TO SUPARTZ. NO FURTHER INCIDENTS TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZAL SODIUM HYALURONATE MOZ SEIKAGAKU CORP. NA 9G369N

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization