BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO

    MDR report key: 2103646 · Received May 20, 2011

    Report

    Report Number
    9612392-2011-00004
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 20, 2011
    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. ON (B)(6) 2011 - A (B)(6) YEAR-OLD FEMALE PT WHO IS A NURSE CONSULTED NEARBY ORTHOPAEDICS. SHE WAS DIAGNOSED WITH OSTEOARTHRITIS OF THE RIGHT KNEE BASED ON X-RAYS. SHE RECEIVED 1ST INJECTION OF ARTZ DISPO. SHE EXPERIENCED REDNESS AND WARMTH OF THE RIGHT KNEE. ON (B)(6) 2011 - SHE VISITED THE ORTHOPAEDICS AND TOLD HER EXPERIENCE TO THE INJECTION PHYSICIAN. THE PHYSICIAN TOLD HER TO TRY ONCE MORE INJECTION OF ARTZ DISPO AND 0.5% PROCAINE HYDROCHLORIDE. ABOUT 10 MINS AFTER SHE RECEIVED THAT INJECTION, SHE EXPERIENCED STRANGE SENSATION OF EYES, NASAL CONGESTION, AND HEAVY NASAL DISCHARGE, PHARYNX CLOSED SENSATION AND COUGH. AND THEN BECAME DYSPNOEA. SHE GREW IN PATIENCE FOR A WHILE BUT HAD NO IMPROVEMENT. ABOUT 20 MINS AFTER THE INJECTION, SHE CONSULTED ANOTHER CLINIC. SHE PRESENTED WITH DYSPNOEA, SEVERE COUGH, MARKED PHARYNGEAL OEDEMA, AND BULBAR CONJUNCTIVA HYPEREMIA AT THE CLINIC. SHE RECEIVED A SHOT OF SAXIZON (HYDROCORTISONE SODIUM SUCCINATE), AND BOSMIN INJECTION (ADRENALINE). SHE IMPROVED. SHE RECEIVED INFUSION DRIP OF FRUCTLACT, SAXIZON AND ASPHAGEN AFTER THAT. ON (B)(6) 2011 - SHE RECOVERED. THE PHYSICIAN RELATED THE EVENT TO ARTZ DISPO BECAUSE THE PT HAD ANAPHYLACTIC SHOCK CLEARLY AFTER THE INJECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening 0.5% PROCAINE HYDROCHLORIDE| CLARITIN (LORATADINE) - PO - 10 MG| (PROCAINE HYDROCHLORIDE) - IR - 5 ML