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

Model Number	F10256-0610G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent paraesophageal hernia repair with ovitex 1s resorbable on (b)(6) 2026.On (b)(6) 2026 the patient reported worsening dysphagia with associated po intolerance.Upper gi imaging was conducted on (b)(6) 2026 which demonstrated delayed esophageal emptying and narrowing at the ge junction.The patient underwent egd with balloon dilation on (b)(6) 2026 and (b)(6) 2026 with no additional interventions noted.
Additional Manufacturer Narrative
Dysphagia is a potential complication noted in the device's instructions for use and is a known complication associated with paraesophageal hernia repair.A batch record review showed no non-conformances or anomalies that may have caused or contributed to the event noted.

• 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: 25854210
• Report Number: 3010513348-2026-00006
• Device Sequence Number: 20131994
• Product Code: FTM
• UDI-Device Identifier: 09421904065291
• UDI-Public: 09421904065291
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2026
• Report Date (Section F): 07/17/2026

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 Expiration Date: 09/30/2026
• Device Model Number: F10256-0610G
• Device Lot Number: ERT-25D06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2026
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2026
• 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; Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 07/17/2026