MAUDE Adverse Event Report: Aroa Biosurgery Ltd. OviTex LPR; Surgical Mesh

Model Number	F10244-1212L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adhesion and bowel obstruction are noted as potential complications in the instructions for use of the device.It cannot be determined whether the device or other patient factors, history, or comorbidities caused or contributed to this event.
Event or Problem Description
A patient underwent ipom hernia repair to address a recurrent ventral hernia with primary closure obtained.Approximately six weeks later, the patient presented with a small bowel obstruction necessitating reoperation.During the procedure adhesions were noted and lysed.A separate internal hernia was discovered and repaired concomitantly.

• Brand Name: OviTex LPR
• 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: 50024234
• Report Number: 3007321028-2026-00028
• Device Sequence Number: 18513841
• Product Code: FTM
• UDI-Device Identifier: 09421904065772
• UDI-Public: 09421904065772
• 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
• 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): 07/27/2026

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 Model Number: F10244-1212L
• 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: 07/23/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown