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

Model Number	F10244-0909L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fluid Discharge (2686)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent open ventral hernia repair for a 4-6cm defect with 9x9cm ovitex lpr placed preperitoneally.The patient returned approximately one week later with redness, swelling, and fluid build up.The surgeon reoperated to explant the device.
Additional Manufacturer Narrative
A batch record review showed no non-conformances or anomalies that may have caused or contributed to the issues noted.No further information was able to be gathered from the reporting surgeon as of the date of this report.Should additional information become available, a follow-up report will be filed.

• 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: 50329015
• Report Number: 50329015
• Device Sequence Number: 17519973
• Product Code: FTM
• UDI-Device Identifier: 09421904065765
• UDI-Public: 09421904065765
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2026
• Report Date (Section F): 08/19/2026

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: F10244-0909L
• Device Lot Number: ERT-25B38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/23/2026
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/19/2026