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

Model Number	F10246-0610P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Dysphagia/ Odynophagia (1815)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aroa's review of manufacturing documentation for the subject lot (ert-24i19) has confirmed that the devices were produced in accordance with the established procedures.All process specifications and final release specifications were satisfied.Dysphagia and perforation 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.
Event or Problem Description
It was reported that a patient underwent hiatal hernia repair with ovitex 1sp and the linx reflux management system on (b)(6) 2025.The patient presented with dysphagia and returned for endoscopy on (b)(6) 2025 where potential entry into the esophagus was noted.The surgeon noted that they plan to perform an additional endoscopy to address the issue.

• 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: 23432855
• Report Number: 3007321028-2025-00044
• Device Sequence Number: 8552039
• Product Code: FTM
• UDI-Device Identifier: 09421904065086
• UDI-Public: 09421904065086
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/17/2025

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: F10246-0610P
• Device Lot Number: ERT-24I19
• 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: 10/02/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Sex: Female