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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION ARTZ DISPO ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORPORATION ARTZ DISPO ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number 4L1B26
Device Problem Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 08/23/2021
Event Type  Injury  
Manufacturer Narrative
This is a definitive report. Four cases were reported from a physician. The physician commented that the cause might be not only artz dispo but also the other factors such as injection procedures. No further information will be expected because the physician refuses to cooperate with us. 480 syringes were delivered to the reported clinic for 3 months. Company comment: according to the result of investigations, 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. 4l1b26. Manufacturer's causality assessment is determined as "not related".
 
Event Description
(b)(6) 2021: a (b)(6) female patient received an injection of artz dispo for gonarthrosis. (b)(6) 2021: she was diagnosed with septic arthritis because staphylococcus aureus was detected.
 
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Brand NameARTZ DISPO
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 Key12587442
MDR Text Key276346282
Report Number9612392-2021-00008
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P980044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number4L1B26
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2021
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: 10/07/2021 Patient Sequence Number: 1
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