BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO

    MDR report key: 2503076 · Received March 21, 2012

    Report

    Report Number
    9612392-2012-00004
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 27, 2012
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE NOW INVESTIGATING THIS CASE.

    Description of Event or Problem · 1

    ADVERSE EVENT: ANAPHYLACTIC SHOCK (SYNCOPE, BRADYCARDIA). ON (B)(6) 2012 - A (B)(6) MALE PATIENT RECEIVED 1ST INJECTION OF ARTZ DISPO TO THE KNEE FOR OSTEOARTHRITIS. AFTER 30 MINUTES, HE FELL DOWN AT THE RECEPTION. HIS PULSE RATE WAS DECREASING TO 50. NO DERMAL SYMPTOM, E.G. REDNESS, WAS OBSERVED. HE RECEIVED IV DRIP FOR TWO HOURS AND RECOVERED. HE WALKED HOME. ON (B)(6) 2012 - HE HAS NOT BEEN VISITED TO THE PHYSICIAN'S OFFICE. ACCORDING TO THE REPORTER THE CASUAL RELATIONSHIP BETWEEN ARTZ DISPO AND THE ADVERSE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ DISPO ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other ROUTE OF ADMIN: DAILY DOSE| INITIAL DATE AND FINAL DATE OF ADMIN| TRADE NAME (GENERIC NAME)