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	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 the 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 was closed.
Additional Manufacturer Narrative
Adhesions and seroma are common after abdominal surgery and may lead to complications resulting in surgical intervention.The ifu states that a potential complication for surgical repair of hernias (with or without surgical mesh) could be seroma and adhesions.In this case the patient required surgery to treat adhesion and seroma.Despite the issues noted the hernia repair remained intact, no additional reinforcement material was added upon second surgery.Aroa's review of manufacturing documents has confirmed that the devices in the applicable lot (ert-21k25) were produced in accordance with the established manufacturing procedures, with all process specifications satisfied.

• 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: 17016133
• Report Number: 3007321028-2023-00012
• Device Sequence Number: 15038799
• Product Code: FTL
• UDI-Device Identifier: 09421904065796
• UDI-Public: 09421904065796
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 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): 05/29/2023

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
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown