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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORP.ARTZ DISPO (=SUPARTZ)SODIUM HYALURONATE

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SEIKAGAKU CORP. ARTZ DISPO (=SUPARTZ) SODIUM HYALURONATE   Back to Search Results
Catalog Number 71567765
Event Date 10/19/2004
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description

Shock, 2004. A pt received 5th injection of artz dispo into left knee for a treatment of osteoathritis of the knee: initial injection for this series was one month prior in 2004. Five to ten min after the injection when they had a seat at the waiting room for outpts, they lost consciousness and fell on the floor. Although their both eyeballs turned upward, their breathing was resumed immediately by a call and they gradually regained consciousness. Arterial oxygen saturation (sa02) showed 100% immediately after the seizure. And then they were admitted to an internal medicine in the hospital one night for observation and received an intravenous drip (1000ml of solulact (lactated ringer's solution)/day) for treatment. Pt was discharged from the hospital because of their complete recovery. Doctor's comment is that the causal relationship between artz dispo and this event is probable because this event occurred 5-10 min after the injection of artz dispo. In 2003, the pt was referred to the hospital from a general practitioner where a hyaluronate preparation (brand name: unknown) had been injected to pt, and an orthopedist at the hospital injected each artz dispo to their both knees. 2003 when any adverse reactions did not occur.

 
Manufacturer Narrative

Company is investigating additional information from the pt's doctor.

 
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Brand NameARTZ DISPO (=SUPARTZ)
Type of DeviceSODIUM HYALURONATE
Baseline Brand NameSUPARTZ
Baseline Generic NameSODIUM HYALURONATE
Baseline Catalogue Number71567765
Baseline Device FamilySUPARTZ
Baseline Device PMA NumberP980044
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)42
Date First Marketed04/04/2001
Manufacturer (Section F)
SEIKAGAKU CORP.
1-5 nihonbashi-honcho,
2-chome, chuo-ku
tokyo
JAPAN 103-0023
Manufacturer (Section D)
SEIKAGAKU CORP.
1-5 nihonbashi-honcho,
2-chome, chuo-ku
tokyo
JAPAN 103-0023
Manufacturer (Section G)
SEIKAGAKU CORPORATION
1-5, nihonbashi-honcho 2-chome
chuo-ku, tokyo
JAPAN 103-0023
Manufacturer Contact
jason chamness
1450 brooks rd
memphis , TN 38116
(901) 399 -5899
Device Event Key544197
MDR Report Key554568
Event Key526940
Report Number9612392-2004-00005
Device Sequence Number1
Product CodeMOZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/12/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/30/2007
Device Catalogue Number71567765
Device LOT Number4F042D
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/19/2004
Device Agena
Event Location Hospital
Date Manufacturer Received10/21/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/12/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
ADOFEED (FLURBIPROFEN), KINEDAK (EPALRESTAT),
BIOPRESS (CANDESARTAN CILEXETIL), ALLEGRA
(FEXOFENADINE HYDROCHLORIDE), EPADEL S (ETHYL
ICOSAPENTATE), NOVOLIN3DR (INSULIN), MEDET
(METFORMIN HYDROCHLOREIDE), METHYCOBAL
(MECOBALAMIN): UNDER CONTINUATION.
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