MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX LPR; SURGICAL MESH

Model Number	F10244-1212L
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aroa's review of manufacturing documentation for the subject lot (ert-24d02) has confirmed that the devices were produced in accordance with the established procedures.All process specifications and final release specifications were satisfied.Pain, adhesion and bowel obstruction are noted as potential complications in the instructions for use of the device.There was no evidence to indicate that the device caused or contributed to the event.A batch record review showed no non-conformances or anomalies that may have caused or contributed to this event.Sterilization was completed as validated and the devices met all release specifications.
Event or Problem Description
A patient underwent incisional hernia repair with intraperitoneal mesh placement (ipom) on approximately (b)(6) 2024, using ovitex lpr for reinforcement.The patient returned with abdominal pain and a ct scan revealed a bowel obstruction.An exploratory laparotomy was performed and the surgeon noted adhesions requiring removal of the device and partial small bowel resection.

• Brand Name: OVITEX LPR
• 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: 20490293
• Report Number: 3007321028-2024-00066
• Device Sequence Number: 11805709
• Product Code: FTM
• UDI-Device Identifier: 09421904065772
• UDI-Public: 09421904065772
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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 Model Number: F10244-1212L
• Device Catalogue Number: F10244-1212L
• Device Lot Number: ERT-24D02
• 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: 09/28/2024
• Initial Report FDA Received Date: 10/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Disability; Hospitalization; Required Intervention
• Patient Sex: Unknown