MAUDE Adverse Event Report: AROA BIOSURGERY 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
Additional Manufacturer Narrative
Adhesions are a common post operative complication of abdominal surgery and may sometimes lead to bowel obstruction and/or small bowel resection.It could not be definitively determined whether the device caused or contributed to the events noted.A batch record (lot) review showed no non-conformances or anomalies that may have caused or contributed to the events noted.This lot was sterilized with the appropriate validated sterilization cycle and all release testing was acceptable.All information known at the time of this report is included.No further information was provided by the reporting surgeon.
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.

• 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: 22877982
• Report Number: 3010513348-2025-00013
• Device Sequence Number: 16058462
• Product Code: FTM
• UDI-Device Identifier: 09421904065130
• UDI-Public: 09421904065130
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2025
• Report Date (Section F): 08/14/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/21/2025
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/14/2025