BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTZ DISPO

    MDR report key: 1579933 · Received January 14, 2010

    Report

    Report Number
    9612392-2010-00001
    Event Type
    Death
    Date Received
    January 14, 2010
    Date of Event
    November 7, 2009
    Report Date
    January 14, 2010
    Manufacturer
    SEIKAGAKU CORP
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE NOW INVESTIGATING THIS CASE.

    Description of Event or Problem · 1

    ADVERSE EVENT: PYOGENIC ARTHRITIS: IN 2009- A FEMALE PT STARTED ARTZ DISPO INJECTION INTO THE KNEE FOR OSTEOARTHRITIS. EIGHT MONTHS LATER - SHE RECEIVED ARTZ DISPO INJECTION. THREE DAYS LATER - SHE COMPLAINED OF KNEE PAIN WORSENED. SHE RECEIVED 1% XYLOCAINE 10 ML INTO THE KNEE, AND LOXOPROFEN FOR PAIN. TWO DAYS LATER - SHE COMPLAINED THAT SHE WAS UNABLE TO WALK DUE TO KNEE PAIN. SHE RECEIVED 1% XYLOCAINE 10 ML. THE FOLLOWING DAY - SHE UNDERWENT ASPIRATION OF 47 ML CLOUDY FLUID, IN WHICH IT WAS REVEALED GRAM-POSITIVE COCCUS LATER. SHE RECEIVED 1% XYLOCAINE 5 ML AND TRIAMCINOLONE ACETONIDE 40 MG INTO THE KNEE. THE FOLLOWING DAY - GENERALIZED ITCHY WHEALS OCCURRED. SHE STARTED DICLOFENAC SUPPOSITORY FOR PAIN. THE NEXT DAY - THE RASH WAS IMPROVED. THE FOLLOWING DAY - SHE RECEIVED 1% XYLOCAINE 10 ML. TWO DAYS LATER - SHE WAS ADMITTED TO THE HOSPITAL EMERGENTLY BECAUSE, HER GENERAL CONDITION WAS WORSENED. HER CONDITION WAS DIAGNOSED AS COMPLICATED DIC WITH SEPTIC SHOCK CAUSED BY PYOGENIC ARTHRITIS. THE FOLLOWING MONTH - SHE DIED. THE PHYSICIAN CONSIDERED THE EVENT RELATED TO ARTZ DISPO INJECTION. THE PHYSICIAN'S COMMENT IS AS FOLLOWS; IT IS THOUGHT THAT THE INJECTION OF THREE DAYS PRIOR TO EVENT, CAUSED GRAM-POSITIVE COCCAL INFECTION IN THE JOINT. THE PATH FOR TRANSMITTING COULD NOT BE DETERMINED WHETHER INFECTION FROM THE INJECTION SITE OR CONTAMINATION IN THE INJECTION SOLUTION OR HEMATOGENOUSLY-DISSEMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ DISPO SODIUM HYALURONATE MOZ SEIKAGAKU CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death HYPEN (ETODOLAC - PO - 400MG -| GASLON N,OD (IRSOGLADINE MALEATE) - PO - UNK