MAUDE Adverse Event Report: SEIKAGAKU CORPORATION MARUNOUCHI CENTER BUILDING SUPARTZ FX; HYALURONIC ACID

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient injected with supartz in both knees experienced severe pain and swelling 2 days post injection.The patient had a follow up visit with there physician on (b)(6) 2024, where x-rays were taken and showed joint effusion.The patient was sent to the emergency room for further treatment.The patient was admitted the same day and discharged 14 days later.The patient was diagnosed with septic arthritis with cultures showing a streptococcal infection.Treatment while in the hospital is unknown.Current patient status is unknown.

• Brand Name: SUPARTZ FX
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): SEIKAGAKU CORPORATION MARUNOUCHI CENTER BUILDING; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo, 100-0 005; JA 100-0005
• MDR Report Key: 20640105
• Report Number: 3009595577-2024-00007
• Device Sequence Number: 20705136
• Product Code: MOZ
• UDI-Device Identifier: 10389130444418
• UDI-Public: (01)10389130444418(17)270331(10)4X3X12
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/08/2024
• Report Date (Section F): 11/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 71564444
• Device Lot Number: 4X3X12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 11/08/2024