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

Device Problem Insufficient Information (3190)

Patient Problem Swelling/ Edema (4577)

Event Date 10/04/2022

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This case was reported from a physician.According to the physician, it was considered that artz dispo was definitely related because her living practice including food, life, and other medicines was not changed other than artz dispo injection and she had swelling face when she received 1st injection of artz dispo.Company comment: it was considered that the swelling face and face edema was probably related to artz dispo because other factors such as physical condition due to aging could be affected.

Event Description

(b)(6) 2022 - at 14:30, an 85 year-old female patient received 1st injection of artz dispo for left gonarthrosis.She had discomfort on her face from the evening.At 19:00, she had swelling face and face edema.2022-10-05 - in the morning, she had swelling face to the extent that she couldn't open her eyelids.She visited this clinic and was admitted.The physician prescribed 100 mg hydrocortone injection (hydrocortisone sodium phosphate) with saline, 25 mg atarax-p parenteral solution (hydroxyzine hydrochloride).Administration of 20 mg predonine (prednisolone) and 120mg allegra (fexofenadine hydrochloride) started.(b)(6) 2022 - she recovered and administration of 20 mg predonine was terminated.(b)(6) 2022- administration of 120 mg allegra was terminated.

• 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: 15711943
• MDR Text Key: 302829281
• Report Number: 9612392-2022-00007
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/05/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 85 YR
• Patient Sex: Female