MAUDE Adverse Event Report: AROA BIOSURGERY LTD. 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 Code	Hernia (2240)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a post-operative seroma followed by hernia recurrence after parastomal hernia repair using ovitex 1s permanent.
Additional Manufacturer Narrative
A review of relevant production records showed no non-conformances or anomalies that may have caused or contributed to this event.Hernia recurrence and seroma are a common known risks of hernia repair with or without the use of surgical mesh.Patient factors such as concomitant surgery and other co-morbidities may have contributed to these events.No known surgical intervention has been performed to address the recurrence as of the date of this report.

• 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: 16273637
• Report Number: 3007321028-2022-00056
• Device Sequence Number: 7492286
• Product Code: FTM
• UDI-Device Identifier: 09421904065093
• UDI-Public: 09421904065093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/31/2023

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: 11/30/2024
• Device Model Number: F10246-1012P
• Device Catalogue Number: F10246-1012P
• Device Lot Number: ERT-21L03
• 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: 01/31/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 93 KG