MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX 1S; SURGICAL MESH

Model Number	F10246-1620P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hernia recurrence is a potential complication after hernia repair with or without the use of supporting material and is noted as a potential complication in the ovitex instructions for use.It cannot be determined whether the device or other patient factors, history, and comorbidities caused or contributed to this event.
Event or Problem Description
A patient underwent incisional hernia repair on (b)(6) 2024.The primary repair included incarcerated bowel which was reduced and primary closure obtained.The patient presented with a bulge in the supraumbilical area in (b)(6) 2025 with suspected hernia recurrence.The hernia was reduced and repaired on (b)(6) 2025 via a robotic tapp hernia repair procedure.

• Brand Name: OVITEX 1S
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland 2022 ; NZ 2022
• MDR Report Key: 23921942
• Report Number: 3010513348-2025-00020
• Device Sequence Number: 13027763
• Product Code: FTM
• UDI-Device Identifier: 09421904065116
• UDI-Public: 09421904065116
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/30/2025
• Report Date (Section F): 12/30/2025

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: F10246-1620P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• 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 Age: 71 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/30/2025