MAUDE Adverse Event Report: AROA BIOSURGERY 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
Adhesion and bowel obstruction are potential complications noted in the device's instructions for use.A batch record review showed no non-conformances or anomalies that may have caused or contributed to the event noted and a root cause could not be determined.
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 may.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; 2 kingsford smith place; airport oaks; auckland 2022 ; NZ 2022
• MDR Report Key: 25829028
• Report Number: 3010513348-2026-00005
• Device Sequence Number: 9740213
• Product Code: FTM
• UDI-Device Identifier: 09421904065796
• UDI-Public: 09421904065796
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2026
• Report Date (Section F): 07/15/2026

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2026
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2026
• 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; Hospitalization; Disability
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/15/2026