MAUDE Adverse Event Report: AROA BIOSURGERY LTD. 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
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.
Additional Manufacturer Narrative
Hernia recurrance is noted as a potential complication in the instructions for use of the device.It cannot be determined whether the device or other patient factors, history, or comorbidities caused or contributed to this event.

• Brand Name: OVITEX 1S
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer Contact: stacey spies ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 23954720
• Report Number: 3007321028-2025-00051
• Device Sequence Number: 13123748
• Product Code: FTM
• UDI-Device Identifier: 09421904065116
• UDI-Public: 09421904065116
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female