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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORPORATION SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Model Number 89130-4444-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hot Flashes/Flushes (2153); Reaction, Injection Site (2442); No Code Available (3191)
Event Date 08/22/2019
Event Type  Injury  
Manufacturer Narrative
This is a definitive report. No further information can be obtained. This case report was received on sep 23, 2019 from the fda as mw5089675 dated sep 16, 2019. It was stated the affected lot number was 4x7207 in the actual letter. Review of the manufacturing records about 4x7z07 and 4x7z01 instead of 4x7207 were performed because there is no corresponding number. According to the results of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot# 4x7z07 and 4x7z01.
 
Event Description
Unk: a female patient received supartz fx injection. (b)(6) 2019: she experienced warmth at injection site, flushing, waves of heat. Her pupils were dilated.
 
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Brand NameSUPARTZ FX
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION
marunouchi center building
6-1, marunouchi 1-chome
chiyoda-ku, 100-0 005
JA 100-0005
Manufacturer (Section G)
SEIKAGAKU CORPORATION - TAKAHAGI PLANT
258-5, aza-matsukubo
oaza-akahama
takahagi-shi, 318-0 001
JA 318-0001
Manufacturer Contact
pharmacovigilance dept.
marunouchi center building
6-1, marunouchi 1-chome
chiyoda-ku, tokyo 100-0-005
JA   100-0005
MDR Report Key9207296
MDR Text Key165960810
Report Number9612392-2019-00015
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Model Number89130-4444-01
Device Catalogue Number7156-4444
Device Lot Number4X7Z07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2019 Patient Sequence Number: 1
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