MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX 1S; SURGICAL MESH

Model Number	F10246-2530P
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unlikely that the device caused or contributed to the anastomotic leak after initial repair.This leak likely led to fistula and abscess formation.While some suture was noted at the skin fistula site and was removed, it did not affect the overall abdominal wall repair and the patient is recovering.
Event or Problem Description
A patient underwent a dual anastomosis case on (b)(6) 2024, during which anastomoses were performed on the upper and lower colon.After this, a complex abdominal wall closure was conducted.The lower anastomosis leaked and the patient was re-admitted on (b)(6) 2024.A ct identified abscess was drained with a second drainage on (b)(6) 2024.A fistula formed from this lower anastomosis.Intestinal failure treatment commenced along with total parenteral nutrition and surgical sclerosis of the fistula until well enough for repair of lower anastomosis fistula which was scheduled for (b)(6) 2025.A skin fistula presented including the presence of polypropylene suture.A reoperation was conducted to remove a portion of suture material with the abdominal wall repair noted to be intact.

• Brand Name: OVITEX 1S
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland 2022 ; NZ 2022
• MDR Report Key: 23437828
• Report Number: 3010513348-2025-00016
• Device Sequence Number: 11957893
• Product Code: FTM
• UDI-Device Identifier: 09421904065727
• UDI-Public: 09421904065727
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2025
• Report Date (Section F): 10/31/2025

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
• Operator of Device: Health Professional
• Device Model Number: F10246-2530P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• 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
• Patient Sex: Female
• Patient Weight: 65 KG
• Date Report Sent to FDA: 10/31/2025