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

Model Number	F10246-2020P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Necrosis (1971)
Date of Event	08/21/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was reported that a patient died from complications of necrotizing enterocolitis approximately three weeks after robotic parastomal sugarbaker hernia repair and one week after onset of enterocolitis.The patient was debrided multiple times unsuccessfully and it was noted that the ovitex device was intact.Necrotizing enterocolitis is an extremely rare complication in adult patients and it is possible that the complication was truly necrotizing fasciitis.The ovitex device is highly unlikely to have contributed to these events, which are generally caused by infection.The ovitex device was reported intact and is terminally sterilized with a validated sterilization cycle.In an abundance of caution, this event is being reported based on the patient outcome.
Event or Problem Description
A patient underwent robotic parastomal sugarbaker hernia repair on (b)(6) 2023 with ovitex.On (b)(6) 2023, the patient presented with necrotizing enterocolitis.The patient was debrided multiple times.The patient passed away approximately one week later.It was reported that the ovitex device was intact.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• 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: tina o'brien ; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 17814836
• Report Number: 3007321028-2023-00024
• Device Sequence Number: 12287264
• Product Code: FTL
• UDI-Device Identifier: 09421904065130
• UDI-Public: 09421904065130
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2023

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: 11/30/2025
• Device Model Number: F10246-2020P
• Device Catalogue Number: F10246-2020P
• Device Lot Number: ERT-22L03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Sex: Unknown