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

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Unk - a female patient received an injection of artz dispo for periarthritis scapulohumeralis since 2019 or earlier.After 2 weeks, she had severe pain and visited a clinic.She was introduced and visited a university hospital.She was diagnosed with septic arthritis.Group b streptococcus was found in synovial fluid.

Manufacturer Narrative

This is a definitive report.The information was provided from japanese distributor.They received it on 2024-04-03.The reporter refused to cooperate investigations completely because the event had more than 5 years ago.According to the physician, it was considered that in the case of a common infection, inflammation would develop in a few days after the injection, but in this case, the infection developed 2 weeks later.The physician interviewed the patient, but there was no information on events that may have caused the infection.It was therefore the causal relationship between the event and artz dispo was unclear.The cause other than artz dispo was diabetes as concurrent disease.Company comment: all of product batches passed with the release test including the sterility test before the product release.It is therefore highly unlikely that the product quality was related to septic arthritis.Manufacturer's causality assessment is determined as "not related".

• 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: marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100 0-005
• MDR Report Key: 19160491
• MDR Text Key: 340801445
• Report Number: 9612392-2024-00005
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female