MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX LPR; SURGICAL MESH

Model Number	F10244-1218L
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	06/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aroa's review of manufacturing documentation for the subject lot (ert-25g22) has confirmed that the devices were produced in accordance with the established procedures.All process specifications and final release specifications were satisfied.Adhesion and bowel obstruction are noted as potential complications in the instructions for use of the device.There was no evidence to indicate that the device caused or contributed to the event.
Event or Problem Description
It was reported by a united kingdom based surgeon that a patient underwent a robotic perineal hernia repair on (b)(6) 2026 with ovitex lpr placed on top of the bladder.The patient was discharged at the end of (b)(6).The patient was re-admitted to the local hospital with a bowel obstruction and underwent re-operation on (b)(6) 2026 where adhesions to the bowel were noted.Bowel resections were performed as needed to address the adhesions.

• 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: 25834235
• Report Number: 3007321028-2026-00023
• Device Sequence Number: 5675377
• Product Code: FTM
• UDI-Device Identifier: 09421904065796
• UDI-Public: 09421904065796
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

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: F10244-1218L
• Device Lot Number: ERT-25G22
• 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: 07/16/2026
• Initial Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Disability; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female