MAUDE Adverse Event Report: Aroa Biosurgery Ltd. 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	05/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent paraesophageal hernia repair with ovitex 1s resorbable on (b)(6) 2026.The patient reported ongoing difficulty advancing beyond a full liquid diet and on 11may26 reported weight loss but overall dysphagia improvement.On (b)(6) 2026 the patient reported worsening dysphagia with associated po intolerance.The patient was admitted to the hospital on (b)(6) 2026 with diagnostic and therapeutic upper endoscopy on (b)(6) 2026 where a retained food bolus was identified in the distal esophagus with mild narrowing of the distal esophagus.A balloon dilation was performed after bolus removal and the patient discharged on (b)(6) 2026.The patient reported in (b)(6) 2026 ongoing improvement in symptoms and appropriate advancement of diet.
Additional Manufacturer Narrative
Aroa's review of manufacturing documentation for the subject lot (ert-25d06) has confirmed that the devices were produced in accordance with the established procedures.All process specifications and final release specifications were satisfied.Dysphagia is noted as a potential complication in the instructions for use of the device.There was no evidence to indicate that the device caused or contributed to the event.

• 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: 50018969
• Report Number: 3007321028-2026-00025
• Device Sequence Number: 9572517
• Product Code: FTM
• UDI-Device Identifier: 09421904065291
• UDI-Public: 09421904065291
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/24/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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; Other
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Weight: 125 LB