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

Model Number	F10246-2020P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bacterial Infection (1735)
Date of Event	06/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a hernia repair (ipom) with ovitex 1s permanent in approximately (b)(6) 2025.The case was planned to be laparoscopic but was converted to open.On (b)(6) 2025, the patient returned to the emergency room and was taken in for surgery.During this surgery, the surgical site appeared infected, and adhesions were present.The device was removed and a small bowel resection performed.
Additional Manufacturer Narrative
Aroa's review of manufacturing documentation for the subject lot (ert-24i03) has confirmed that the devices were produced in accordance with the established procedures.All process specifications and final release specifications were satisfied.Adhesion, bowel obstruction, and infection are noted as potential complications in the instructions for use of the device.There was no evidence to indicate that the device caused or contributed to the 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: 22881649
• Report Number: 3007321028-2025-00038
• Device Sequence Number: 15860933
• Product Code: FTM
• UDI-Device Identifier: 09421904065130
• UDI-Public: 09421904065130
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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
• Device Model Number: F10246-2020P
• Device Lot Number: ERT-24I03
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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; Required Intervention
• Patient Sex: Unknown