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

Lot Number 4C3A24

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Nausea (1970); Dizziness (2194); Diaphoresis (2452); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/27/2023

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This case was reported from a hospital to chinese authority, the chinese sale partner received it on 2023-09-11, 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# 4c3a24.We selected the code of 4581 (appropriate term/code not available) for h.6 health effect clinical code because "palpitations" was not listed in annex e.

Event Description

(b)(6) 2023 - a 40-year-old female patient weighing 60kg received an injection of artz dispo for knee osteoarthritis.(b)(6) 2023 - she was treated with artz dispo injection.(b)(6) 2023 - she was treated with artz dispo injection.(b)(6) 2023 - she came to the hospital again.She complaining of dizziness, headache (pain in the forehead and the top of the head, the whole headache, aggravated when the body position changed), nausea but not vomiting, palpitation, sweating and other uncomfortable symptoms after taking the medicine on (b)(6).No above symptoms exist before taking the medicine on (b)(6).The doctor considered that it might be related to the use of artz dispo injection and stopped taking the medicine.Head ct scan was performed.No obvious signs of emergency were found on emergency head ct.There were negative findings on ct scan in the early stage of cerebral infarction.The doctor recommended promethazine hydrochloride injection 25mg st im, 0.9% sodium chloride injection 250ml + gastrodin injection 0.6g st ivgtt, flunarizine hydrochloride tablet 5mg qn po for symptomatic treatment.(b)(6) 2023 - she came to the hospital again and complained that her symptoms did not improve after treatment and she had sleep disorders at night.The doctor advised her to change to 6mg tid po of betaustine mesylate tablets, 2 tid po of ginkgo biloba leaves, 10ml bid po of soothing brain tonic liquid and 0.5mg tid po of mecobalamine tablets for further symptomatic treatment.(b)(6) 2023 - she came to the hospital again and complained that the appeal symptoms such as headache and dizziness were better than before.

• 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
• Manufacturer (Section G): SEIKAGAKU CORPORATION - TAKAHAGI PLANT; 258-5, aza-matsukubo; oaza-akahama; takahagi-shi, ibaraki 318 0 001; JA 318 0001
• Manufacturer Contact: 6-1, marunouchi 1-chome; marunouchi center building; chiyoda-ku, tokyo 100 0-005
• MDR Report Key: 17873597
• MDR Text Key: 324961003
• Report Number: 9612392-2023-00005
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 4C3A24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 60 KG