BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZAL

    MDR report key: 1668162 · Received April 26, 2010

    Report

    Report Number
    9612392-2010-00003
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    August 30, 2009
    Report Date
    April 26, 2010
    Manufacturer
    SEIKAGAKU CORP
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL IMPLANT DATES: (B) (6) 2009, (B) (6) 2009. THIS IS A CONSUMER'S REPORT FROM (B) (6) THROUGH THE SALES PARTNER, AND A DEFINITIVE REPORT. THIS IS A SPONTANEOUS REPORT FROM A PT. NO ADDITIONAL INFO FROM THE PHYSICIAN IS AVAILABLE. OUR MEDICAL ADVISER'S COMMENT: THIS CAUSE OF THE FACIAL PARALYSIS REMAINS UNCLEAR BASED ON SEVERAL TESTS INCLUDING BORRELIA. IT WOULD BE CONSIDERED ACCIDENTAL SYMPTOMS. GENERALLY, IT IS DIFFICULT TO SPECIFY THE CAUSE OF THE FACIAL PARALYSIS, WHICH IS NOT INDUCED BY PHARMACEUTICALS, AND THIS IS THE FIRST CASE IN THE MARKET EXPERIENCE OF ARTZAL. THEREFORE, THIS CASE IS UNLIKELY TO RELATE TO ARTZAL INJECTION.

    Description of Event or Problem · 1

    ADVERSE EVENT: FACIAL PARALYSIS, FEVER, FATIGUE. ON 2009 (B) (6) - A FEMALE PT RECEIVED ARTZAL INJECTIONS IN BOTH KNEES FOR OSTEOARTHRITIS. ON 2009 (B) (6) - SHE RECEIVED 2ND ARTZAL INJECTIONS IN BOTH KNEES. ON 2009 (B) (6) - SHE RECEIVED 3RD ARTZAL INJECTIONS IN BOTH KNEES. ON 2009 (B) (6) - A FEW DAYS LATER, SHE FELT FEVERISH. SHE WAS HOSPITALIZED SINCE THE MOUTH WAS HANGING AND THE EYE FELT STRANGE. A BLOOD CLOT WAS SUSPECTED SINCE SHE PREVIOUSLY HAD HAD ONE. ON 2009 (B) (6) - AFTER APPROXIMATELY 24 HRS AFTER THE HOSPITALIZATION, SHE RECEIVED THE DIAGNOSIS FACIAL PARALYSIS AND TREATMENT WITH CORTISON WAS INITIATED. ON 2009(B) (6) - SHE IS STILL BEING CHECKED UP AT EYE CLINIC AND EAR, NOSE THROAT AND HAS STILL FEVER. THE FEVER DAILY VARIES BETWEEN 37.6-38.8 DEGREES CELSIUS STILL AFTER A MONTH. THE PHYSICIAN HAS TAKEN SEVERAL SAMPLES (E.G BORRELIA), BUT STILL NO EXPLANATION TO THE FEVER. THE PT MUST ALSO USE OINTMENT FOR THE EYE EVERY DAY AND A MOIST CHAMBER SINCE SHE CAN'T BLINK. THE SKEWNESS OF THE MOUTH IS IMPROVING. THE PT CANNOT WORK DUE TO THE FATIGUE AND EYE PROBLEM. NO FURTHER INFO IS CURRENTLY AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization GLUCOSINE (GLUCOSAMINE) - UNK| TROMBYL (ASPIRIN) - 160MG| SIMVASTATIN - 20MG| NEXIUM ENTEROTABLETS (ESOMEPRAZOLE) - 40MG| LASIX RETARD (FUROSEMIDE) - 30MG| ENALAPRIL ACTAVIS TABLETS - 10MG