MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX LPR; Mesh, surgical

Model Number	F10244-0909L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Erosion (1750); Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aroa's review of manufacturing documentation for the subject lot (ert-24i15) has confirmed that the devices were produced in accordance with established procedures and all process and final release specifications were satisfied.Adhesions, perforation, and infection 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
A patient underwent hernia repair with ovitex lpr on (b)(6) 2025.The surgeon sewed the device in place and also utilized a capsure tacker (permanent stainless steel and peek).The patient returned symptomatic for abscess and underwent exploratory laparotomy approximately 5 weeks later.Upon reoperation, it was noted that adhesions were present along with some erosion into the bowel.The product and a portion of the bowel were excised.

• Brand Name: OVITEX LPR
• Common Device Name: Mesh, surgical
• Manufacturer (Section D): AROA BIOSURGERY; 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: 21746824
• Report Number: 3007321028-2025-00016
• Device Sequence Number: 19798973
• Product Code: FTM
• UDI-Device Identifier: 09421904065765
• UDI-Public: 09421904065765
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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
• Device Model Number: F10244-0909L
• Device Catalogue Number: F10244-0909L
• Device Lot Number: ERT-24I15
• 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: 02/26/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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: Disability; Required Intervention; Hospitalization
• Patient Sex: Female