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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
On (b)(6) 2021 - a (b)(6) female patient received an injection of artz dispo for gonarthrosis. On (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
MDR Report Key12587431
MDR Text Key281757004
Report Number9612392-2021-00006
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P980044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
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 Received10/06/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/06/2021 Patient Sequence Number: 1
Treatment
ANALGESICS; ANTIPYRETIC
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