BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO (=SUPARTZ)

    MDR report key: 1033379 · Received April 22, 2008

    Report

    Report Number
    9612392-2008-00002
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 22, 2008
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OUR MEDICAL ADVISER SUGGESTED AS FOLLOWS: THIS ADVERSE EVENT OCCURRED IMMEDIATELY AFTER THE ARTZ DISPO INJECTION, BUT SINCE NO SKIN SYMPTOMS LIKE RASH, BREATHING DIFFICULTY, AND FACIAL EDEMA DEVELOPED, IT IS DIFFICULT TO CONSIDER THE ADVERSE EVENT AS ANAPHYLACTIC SHOCK. IT IS BELIEVED THE PRIMARY SHOCK ASSOCIATED WITH ARTZ DISPO INJECTION.

    Description of Event or Problem · 1

    EVENT: BLOOD PRESSURE DECREASED, NAUSEA. IN 2007 - A FEMALE PT STARTED ARTZ DISPO (=SODIUM HYALURONATE) INJECTION INTO THE KNEE FOR OSTEOARTHRITIS ONCE A WEEK. IN 2007, THE INJECTION INTERVAL WAS CHANGED TO EVERY TWO WEEKS. IN 2008 - SHE COMPLAINED OF KNEE PAIN AND DISCOMFORT AFTER THE INJECTION AT 10:30 AM. THE BLOOD PRESSURE WAS 100/80 MMHG. THE INJECTING PHYSICIAN LAID HER ON THE BED FOR CONTINUOUS NAUSEA AND DIZZINESS. THEN HE TOOK HER BLOOD PRESSURE. HER BLOOD PRESSURE DROPPED TO 80/60 MMHG. HER CONSCIOUSNESS WAS CLEAR. SHE ALSO COMPLAINED OF NUMBNESS IN LEFT LEG. THOUGH A DRIP INFUSION WAS CONDUCTED, THE SYMPTOMS STILL PERSISTED. CONSEQUENTLY, SHE WAS TRANSFERRED TO AN EMERGENCY HOSP AT 11:30 AM. THE BLOOD PRESSURE WAS 100/80 MMHG AT THAT TIME. IT IS NO AVAILABLE ON THE DETAILED INFO IN REGARD TO THE TREATMENT AND THE SYMPTOM; BLOOD PRESSURE DECREASED, REOCCURRED AT THE EMERGENCY HOSP. SHE REC'D INFUSION THERAPY AND RECOVERED IN THE DAY. THE INJECTING PHYSICIAN CONSIDERED THAT THIS EVENT WAS PROBABLY RELATED TO ARTZ DISPO. THE INJECTING PHYSICIAN CONSIDERED THAT THIS EVENT WAS ALSO RELATED TO AUTONOMIC REFLEX. THE INJECTING PHYSICIAN CONSIDERED DECREASING BLOOD PRESSURE WAS SERIOUS EVENT, BUT NAUSEA WAS NOT SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ DISPO (=SUPARTZ) SODIUM HYALURONATE MOZ SEIKAGAKU CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other MOHRUS 30 (KETOPROFEN)-TOPICAL-2 SHEETS-