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 Code	Erosion (1750)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent hiatal hernia surgery repair reinforced with ovitex 1s.Approximately 6 months later, the patient underwent reoperation for suspected potential esophageal erosion.Upon reoperation the surgeon noted a small piece of polypropylene suture in apposition to the esophagus.The suture was removed without incident and the patient had no further complications.The device was reported to have otherwise been integrated and remodeled.

• 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: 22322602
• Report Number: 3010513348-2025-00007
• Device Sequence Number: 8812441
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2025
• Report Date (Section F): 06/24/2025

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 Catalogue Number: F10246-0610P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/11/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/24/2025