BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ

    MDR report key: 3251701 · Received July 8, 2013

    Report

    Report Number
    9612392-2013-00003
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 6, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DEFINITIVE REPORT. OUR MEDICAL ADVISER'S COMMENT: CULTURE RESULTS WERE NOT MENTIONED IN THIS CASE THOUGH, IT SHOULD BE OF INFECTIOUS ARTHRITIS ON THE BASIS OF CRP, ESR AND THE FACT THE PT HAD FEVER AND WAS TREATED WITH ANTIBIOTICS. THIS CASE IS MORE LIKELY TO BE INFECTIOUS ARTHRITIS CAUSED BY INJECTION PROCEDURES AND SO ON.

    Description of Event or Problem · 1

    ADVERSE EVENT: SEPTIC ARTHRITIS NOS, EDEMA ON LEFT KNEE, FEVER, PAIN. (B)(6) 2013, A FEMALE PT RECEIVED ARTZ INJECTION BILATERALLY FOR GONARTHROSIS. (B)(6) 2013, SHE RECEIVED THE 4TH INJECTION IN BOTH KNEES. (B)(6) 2013, SHE EXPERIENCED EDEMA TO THE LEFT KNEE ONLY, WHICH CAUSED PAIN AND FEVER. (B)(6) 2013, THE PHYSICIAN ASPIRATED 3 VIALS OF FLUID FROM HER KNEE. (B)(6) 2013, DUE TO THE PERSISTENCE OF THE SYMPTOMS, SHE PRESENTED TO THE EMERGENCY ROOM BUT NO ACCURATE DIAGNOSIS WAS DONE. (B)(6), 2013, FOUR VIALS OF FLUID WERE ASPIRATED AGAIN FROM THE KNEE. (B)(6) 2013, FOUR VIALS OF FLUID WERE ASPIRATED AGAIN FROM THE KNEE. (B)(6) 2013, SHE PRESENTED AGAIN TO THE ER AND 3 VIALS OF FLUID WERE ASPIRATED. THE FLUID WAS EXAMINED (NO RESULT PROVIDED). AN ANTIBIOTIC THERAPY WAS PRESCRIBED FIRST FOR 20 DAYS PROLONGED TO 30 DAYS BECAUSE THE FEVER WAS CONTINUING. BLOOD TESTS ON AN UNSPECIFIED DATES AND REPEATED FOR 4 TIMES, REVEALED ESR 120 AND C-PROTEIN 184. (B)(6) 2013, FEVER, PAIN AND EDEMA CONTINUED UNTIL THE END OF (B)(6). SHE REPORTED THAT AS A RESULT OF FORCED IMMOBILIZATION AND SWELLING, THE MUSCLES OF THE LEG WERE COMPLETELY BLOCKED AND SHE HAD TO UNDERGO A COURSE OF PHYSIOTHERAPY THAT IS CONTINUING. (B)(6)2013, SYMPTOMS IMPROVED; THE EDEMA IS STILL PRESENT AND THE PAIN OCCURS WHEN SHE IS WALKING. A KNEE NMR IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309497 ARTZ SODIUM HYALURONATE MOZ SEIKAGAKU CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TRADE NAME(GENERIC NAME)-ROUTE OF ADMIN -| DAILY DOSE