MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL GELSYN; HYALURONIC ACID

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Swelling/ Edema (4577)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient was diagnosed with an infection after receiving a gelsyn injection.The patient had their fist injection on (b)(6) 2024.Two days post injection the patient experienced swelling without signs of infection at the injection site.A follow up with the physician was conducted by the paitent, the physician advised the patient to apply cold compress and if symptoms did not improve, seek urgent medical care.Three days post injection the patient went to the urgent care where cultures were taken and tested positive for strep.The patient underwent three knee draining procedures and was treated with antibiotics.Patient was admitted to the hospital to undergo a washout procedure and additional antibiotic treatment.The patient was discharged from the hospital and reported as improving.
Additional Manufacturer Narrative
Correction: b4 corrected with initial date reported to the fda.

• Brand Name: GELSYN
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL; via martiri di cefalonia; lodi, 2-269 00; IT 2-26900
• MDR Report Key: 19353052
• Report Number: 3009595577-2024-00002
• Device Sequence Number: 7299082
• Product Code: MOZ
• UDI-Device Identifier: 08033638951057
• UDI-Public: (01)08033638951057(10)A10438(17)2025-11-21
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024
• Report Date (Section F): 04/30/2024

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 Expiration Date: 11/21/2025
• Device Model Number: N/A
• Device Catalogue Number: GS3111
• Device Lot Number: A10438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/30/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 11/20/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male