MAUDE Adverse Event Report: AROA BIOSURGERY 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
Dysphagia and perforation (i.E.Erosion) are noted as possible adverse events reported associated with hernia repair in the ovitex instructions for use.A batch record review showed no non-conformances or anomalies that may have 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 in (b)(6) 2025 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; 2 kingsford smith place; airport oaks; auckland 2022 ; NZ 2022
• MDR Report Key: 23323099
• Report Number: 3010513348-2025-00015
• Device Sequence Number: 9949177
• Product Code: FTM
• UDI-Device Identifier: 09421904065086
• UDI-Public: 09421904065086
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2025
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/01/2025
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• 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: Female
• Date Report Sent to FDA: 10/17/2025