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

Device Problem Insufficient Information (3190)

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

This is a definitive report. This case was reported from a pharmacist. The reporter stated a patient had the event after hyaluronic acid injection but didn't provide the patient's identification. We regard that artz dispo was used and suspected, but we consider the information was insufficient to evaluate causality.

Event Description

Unk - a patient received a hyaluronic acid intra-articular injection for osteoarthritis. Usage of artz dispo cannot be ruled out. The patient had anaphylactic shock. The outcome was unknown.

• 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: 12305535
• MDR Text Key: 265991776
• Report Number: 9612392-2021-00004
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/15/2021
• 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 Treatment Data

Date Received: 08/11/2021 Patient Sequence Number: 1