MAUDE Adverse Event Report: AROA BIOSURGERY LTD. 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	Hernia (2240)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device problem was found from review of the dhr.The devices in lot ert-22c18 were produced as per established manufacturing procedures.All process specifications including package labeling requirements were met.Hernia recurrence is noted as a potential complication in the instructions for use.There was no evidence to indicate that the device directly caused or contributed to the event.
Event or Problem Description
It was reported that a patient experienced a hernia recurrence approximately 14 months after ventral/incisional hernia repair.The patient underwent reoperation to repair the hernia recurrence and to remove the originally implanted device.

• 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: 18956630
• Report Number: 3007321028-2024-00022
• Device Sequence Number: 4500652
• Product Code: FTM
• UDI-Device Identifier: 09421904065796
• UDI-Public: 09421904065796
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: 02/28/2025
• Device Model Number: F10244-1218L
• Device Catalogue Number: F10244-1218L
• Device Lot Number: ERT-22C28
• 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: 03/18/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White