MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX REINFORCED TISSUE MATRIX; SURGICAL MESH

Model Number	F10244-0909L
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	09/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient returned to the hospital with abdominal pain on (b)(6) 23 after umbilical hernia repair with ovitex lpr originally performed on (b)(6) 2023.A ct scan showed bowel obstruction which was addressed with surgery and partial device removal.It was noted that the bowel was stuck in two places requiring sharp dissection and partial bowel resection.A bowel anastomosis was performed and surgery completed without further reinforcement.
Additional Manufacturer Narrative
Adhesions are common events after abdominal surgery with or without the use of surgical mesh.Adhesions and bowel obstruction are noted as potential complications in the instructions for use.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 17878158
• Report Number: 3010513348-2023-00009
• Device Sequence Number: 17989348
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2023
• Report Date (Section F): 10/05/2023

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 Expiration Date: 08/31/2025
• Device Model Number: F10244-0909L
• Device Catalogue Number: F10244-0909L
• Device Lot Number: ERT-22I28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2023
• 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; Disability
• Patient Age: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/05/2023