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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 4C1B03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033)
Event Date 09/11/2021
Event Type  Injury  
Event Description
On (b)(6) 2021 an (b)(6) year-old female patient weighing (b)(6) kg was admitted to the hospital for mixed cervical spondylopathy, osteoarthritis in both knees. On (b)(6) 2021, she received sodium hyaluronate injection into the joint cavity of both knees, each 25mg at the hospital. On (b)(6) 2021 her abdomen was itchy, she didn't care. On (b)(6) 2021 her abdomen was accompanied by a small amount of scattered rash. It was considered allergic dermatitis. She was continued to observe. On (b)(6) 2021 her abdomen with skin rashes increased significantly, and she was given 10mg loratadine tablets orally once a day, 5% glucose injection + 20ml calcium gluconate injection intravenously, once a day. On (b)(6) 2021 her limbs, chest and abdomen appeared rash with itching, and intravenous infusion of methylprednisolone sodium succinate was added. On (b)(6) 2021 her skin rash and itching all over her body disappeared.
 
Manufacturer Narrative
This is a definitive report. This case was reported from a hospital to (b)(6) authority, and it was forwarded to manufacturer. The reporter did not provide any further information. 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 # 4c1b03.
 
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Brand NameARTZ DISPO
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi 1-chome
marunouchi center building
chiyoda-ku, tokyo 100-0 005
JA 100-0005
MDR Report Key12620645
MDR Text Key280696045
Report Number9612392-2021-00009
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 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number4C1B03
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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