MAUDE Adverse Event Report: AROA BIOSURGERY LTD. 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
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 readmitted 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 on (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.
Additional Manufacturer Narrative
Aroa was unable to conduct a review of manufacturing documentation since the lot number for the device was available.A review of the risk management file determined no additional risk control measures are warranted.Abscess and fistula 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.

• Brand Name: OVITEX 1S
• 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: 23511899
• Report Number: 3007321028-2025-00046
• Device Sequence Number: 9704628
• Product Code: FTM
• UDI-Device Identifier: 09421904065727
• UDI-Public: 09421904065727
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K181935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 65 KG