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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 Insufficient Information (3190)
Patient Problem Stroke/CVA (1770)
Event Date 10/27/2020
Event Type  Injury  
Manufacturer Narrative
This case is received on november 19, 2020 from the fda as mw5097583 dated: november 10, 2020, which was directly reported to the fda by the patient. Follow-up attempts to the reporter are underway.
 
Event Description
On (b)(6) 2020, a female patient had been in the hospital. She had a stroke and blindness.
 
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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, tokyo 100-0 005
JA 100-0005
Manufacturer (Section G)
SEIKAGAKU CORPORATION - TAKAHAGI PLANT
258-5, aza-matsukubo
oaza-akahama
takahagi-shi, ibaraki 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 Key11038437
MDR Text Key223066496
Report Number9612392-2020-00015
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number89130-4444-01
Device Catalogue Number7156-4444
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
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
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
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