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

Lot Number 4C1G20

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This case was reported from a hospital to chinese 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# 4c1g20.

Event Description

On (b)(6) 2022 a female patient of unknown age and weight of 62 kg was given artz dispo injection once a week for maintenance treatment due to "bilateral knee osteoarthropathy" after discharge.After she was discharged from the hospital, she developed a rash all over the body for unknown reasons, itching was unbearable, accompanied by scratches all over the body, so she went to the dermatology outpatient clinic.The doctor asked the patient's medical history and medication history, considering that it was an adverse drug reaction caused by sodium hyaluronate injection, and instructed the patient to stop the drug.On (b)(6) 2022 the patient returned to the outpatient clinic and complained that the rash symptoms were relieved but not cured after the drug was discontinued, and the sodium hyaluronate continued to be used due to the original disease, and the symptoms worsened again, which was more serious than before.

• Brand Name: ARTZ DISPO
• Type of Device: ACID, 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 Key: 15606852
• MDR Text Key: 301743753
• Report Number: 9612392-2022-00005
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Lot Number: 4C1G20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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): Hospitalization; Other
• Patient Sex: Female