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 Code	Hernia (2240)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adhesions are a common event after abdominal surgery and may lead to complications resulting in surgical intervention.The ifu states that a potential complication for surgical report of hernias (with or without surgical mesh) could be hernia recurrence or adhesion.Aroa's review of manufacturing documents has confirmed that the devices in the applicable lot (ert-21a13) were produced in accordance with the established manufacturing procedures, with all process specifications satisfied.
Event or Problem Description
A patient underwent hernia repair with ovitex 1sp on (b)(6) 2022.The repair was robotically completed (ipom) with fascial closure.The patient returned in late (b)(6) 2023 complaining of pain with ct scan confirming a hernia recurrence.Surgery was conducted on (b)(6) 2023 to address the recurrence at which point bowel adhesions were noted.The surgeon performed adhesiolysis to separate bowel from the remaining device.Hernia reduction was achieved and the hernia repaired.

• 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: daniel dantzic ; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• MDR Report Key: 17016113
• Report Number: 3007321028-2023-00013
• Device Sequence Number: 6957183
• Product Code: FTM
• UDI-Device Identifier: 09421904065130
• UDI-Public: 09421904065130
• 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: 2021
• Device Explanted 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): 05/19/2023

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: 12/31/2023
• Device Model Number: F10246-2020P
• Device Catalogue Number: F10246-2020P
• Device Lot Number: ERT-21A13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female