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

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 03/03/2023

Event Type  Injury  

Event Description

2013-unk - a female patient, who is 73 years old as of 2023, started an injection of artz dispo for periarthritis scapulohumeralis.(b)(6)2023 - she received mixed injections of artz dispo and xylocaine to biceps long head tendon sheath of bilateral shoulders.(b)(6) 2023- she had pain on left shoulder.Infection developed.Her right shoulder had no problem.(b)(6) 2023- an injecting physician confirmed swelling around subacromial bursa.Culture test resulted that staphylococcus aureus was positive.She started to take penicillin and rocephin.(b)(6) 2023 - the physician referred to another hospital.(b)(6) 2023 - she terminated to receive penicillin and rocephin.(b)(6) 2023 - the range of motion of her shoulder was 120 degrees.Infection was resolving.(b)(6) 2023- culture test resulted negative.

Manufacturer Narrative

This is a definitive report.This case was reported from a physician.The lot number of artz dispo was unknown.The indication for use was bilateral periarthritis scapulohumeralis and infection developed on left shoulder only.According to the reporting physician, this is the first time he has experienced an infection after injecting artz dispo since 2013.Disinfection is performed in duplicate.It was considered that the cause of infection was not assessable to whether artz dispo and xylocaine.Company comment: all of product batches passed with the release test including the sterility test before the product release.Furthermore, no infection has been reported from other facilities except for this case.It is therefore highly unlikely that the product quality was related to the infection.Manufacturer's causality assessment is determined as "not related".

• 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: 16713277
• MDR Text Key: 313030878
• Report Number: 9612392-2023-00002
• 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: 03/20/2023

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: 03/22/2023
• Initial Date FDA Received: 04/11/2023
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Female