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

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.

• Brand Name: ARTZ DISPO
• Type of Device: ACID, 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 Key: 12620645
• MDR Text Key: 280696045
• Report Number: 9612392-2021-00009
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 4C1B03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 84 YR
• Patient Weight: 46