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

Model Number	F10246-1012P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bacterial Infection (1735); Obstruction/Occlusion (2422)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a post-operative infection and bowel obstruction.The latter led to bowel obstructive symptoms and re-operation where adhesions were noted.The device was removed after adhesions were freed.There was no reported permanent damage.
Additional Manufacturer Narrative
A batch record review showed no non-conformances or anomalies that may have caused or contributed to this event.Sterilization was completed as validated and the devices met all release specifications.It is unlikely that the device caused or contributed to the infection noted.Adhesions are common after abdominal surgery with or without the use of surgical mesh and thus adhesions and bowel obstruction are noted as possible 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: 19951531
• Report Number: 3010513348-2024-00016
• Device Sequence Number: 12986224
• Product Code: FTM
• UDI-Device Identifier: 09421904065093
• UDI-Public: 09421904065093
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2024
• Report Date (Section F): 08/09/2024

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: 07/31/2026
• Device Model Number: F10246-1012P
• Device Catalogue Number: F10246-1012P
• Device Lot Number: ERT-23H17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2024
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• 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: 58 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/09/2024