BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ (=SUPARTZ)

    MDR report key: 499374 · Received December 5, 2003

    Report

    Report Number
    9612392-2003-00008
    Event Type
    Injury
    Date Received
    December 5, 2003
    Date of Event
    November 5, 2003
    Report Date
    December 5, 2003
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003, THE PT COMPLAINED ABOUT JOINT PAIN OF RIGHT KNEE AND VISITED A HOSPITAL. AT THE HOSPITAL, 6:50 PM, 14ML OF JOINT FLUID WAS DRAINED BY ARTHROCENTESIS. THEY RECEIVED 2ML OF 1% CARBOCAIN (MEPIVACAINE HYDROCHLORIDE) FOR REGIONAL ANESTHESIA, AND THEN THEY RECEIVED 2.5ML OF ARTZ, 2ML OF 1% CARBOCAIN AND 2MG OF "RINDERON" (BETAMETHASONE SODIUM PHOSPHATE) INTO THEIR RIGHT KNEE JOINT. DURING X-RAY PHOTOS BEING TAKEN AT 7:00PM, EXANTHEMA APPEARED ON THEIR WHOLE BODY. AS THEY COMPLAINED ABOUT DYSPNEA THEIR DOCTOR KEPT PT IN A RECUMBENT POSITION IMMEDIATELY, AND INJECTED "SOLU-CORTEF" (HYDROCORTISONE SODIUM SUCCINATE) 200MG THROUGH BYPASS AND GAVE PT A DRIP OF "SOLU-CORTEF" 200MG, ATTACHING A MONITOR TO PT 2-3 MINUTES LATER, THEIR BLOOD PRESSURE RECOVERED FROM 80MMHG TO 110-120MMHG. AN INHALATION TREATMENT WITH O2 AT 3L/MIN WAS INITIATED BECAUSE THEIR SPO2 DECREASED TO 88%. ALSO THEY TOOK "PREDONINE" (PREDNISOLONE) 10MG AND "EBASTEL" (EBASTINE) 1 TAB. AT 7:20 PM, UNDER AN INHALATION TREATMENT WITH O2 AT 3L/MIN. SPO2 AND BLOOD PRESSURE SHOWED 93% AND 140/66MMHG RESPECTIVELY. AT 8:00 PM, UNDER THE INHALATION TREATMENT WITH O2 AT 3L/MIN, SPO2 AND BLOOD PRESSURE SHOWED 96% AND 135/75MMHG RESPECTIVELY, AND THEIR DYSPNEA IMPROVED. AT 8:45 PM, THE INHALATION TREATMENT WITH O2 WAS DISCONTINUED. UNDER ROOM AIR, SPO2 AND BLOOD PRESSURE SHOWED 95% AND 135/71MMHG RESPECTIVELY. AT 9:00 PM, SPO2, PULSE RATE AND BLOOD PRESSURE SHOWED 96%. 74/MINUTES AND 118/59MMHG RESPECTIVELY. THEIR RESPIRATORY STATE WAS IN GOOD CONDITION. AT 9:15 PM, EXANTHEMA STILL EXISTED OF THEIR WHOLE BODY, BUT THE DOCTOR ALLOWED THEM TO GO HOME BECAUSE THEY IMPROVED FROM DYSPNEA. THE FOLLOWING DAY, THEY RECOVERED FROM EXANTHEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ (=SUPARTZ) SODIUM HYALURONATE MOZ SEIKAGAKU CORP. NA 3E854A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other 2. RINDERON (BETAMETHASONE SODIUM PHOSPHATE).| 1. CARBOCAIN (MEPIVACAINE HYDROCHLORIDE),