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

Model Number	F10244-1218L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced persistent drainage after the use of ovitex lpr in robotic ventral hernia repair.The surgeon re-operated to assess the surgical site.Upon site assessment it appeared that the device had partially integrated.Non-integrated portions of the device were removed and the patient closed.
Additional Manufacturer Narrative
Despite the issues noted, the hernia repair remained intact and no additional reinforcement material was added upon second surgery.It was reported on (b)(6) 2023 that the patient was recovering with no ongoing issues noted.

• 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: 16997010
• Report Number: 3010513348-2023-00005
• Device Sequence Number: 3377597
• Product Code: FTM
• UDI-Device Identifier: 09421904065796
• UDI-Public: 09421904065796
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/24/2023
• Report Date (Section F): 05/24/2023

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: 10/31/2024
• Device Model Number: F10244-1218L
• Device Catalogue Number: F10244-1218L
• Device Lot Number: ERT-21K25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2023
• 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; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/24/2023