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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 Problem Urinary Tract Infection (2120)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative
This is a definitive report. This was reported from a staff of physician's clinic and the physician confirmed the event. According to the physician's staff, they were wondering if the injection was possibly contaminated, because they were unsure of why he got so ill. Injection physician stated it was very unlikely that the injection was contaminated or that it caused his infections. According to the result 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 no. 4x7c29. Furthermore, no infectious event has been reported from other facilities in the us except for this case, the urinary tract infection was therefore not related to product quality. It was considered that the causal relationship was "not related" because community-acquired infection could be suspected. (b)(4).
 
Event Description
On (b)(6) 2017 - a male patient received 1st injection of supartz fx to the knee for osteoarthritis. On (b)(6) 2017 - he received 2nd injection of supartz fx. On (b)(6) 2017 - he received 3rd injection of supartz fx. On (b)(6) 2017 - he received 4th injection of supartz fx. He was vomiting at night. On (b)(6) 2017 - he ended up in the er with a fever. He was diagnosed with e. Coli and an urinary tract infection. On (b)(6) 2017 - he was taking medications that were prescribed. He was feeling a little bit better.
 
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Brand NameSUPARTZ FX
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION
pharmacovigilance dept.
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-aka
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 Key7182183
MDR Text Key96972273
Report Number9612392-2018-00001
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 12/13/2017,12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Model Number89130-4444-01
Device Catalogue Number7156-4444
Device Lot Number4X7C29
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/12/2017
Device Age8 MO
Event Location No Information
Date Report to Manufacturer12/13/2017
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2017
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: 01/11/2018 Patient Sequence Number: 1
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