MAUDE Adverse Event Report: AROA BIOSURGERY 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
Abdominal surgery carries risk of adhesions regardless of whether a surgical implant is utilized.This risk may be exacerbated by intraperitoneal placement of surgical mesh which may lead to visceral adhesions.It was reported that this surgical plane was the only plane available for device placement for this particular patient.
Event or Problem Description
A patient underwent incisional hernia repair via intraperitoneal placement of mesh (ipom) on (b)(6) 2024 with ovitex lpr placed as reinforcement.The patient complained of abdominal pain approximately one week later.Approximately one week after presenting with pain, ct scan revealed a bowel obstruction.Upon exploratory laparotomy, adhesions were noted.Takedown of adhesions required device removal and some small bowel resection.While the device was not noted as definitively related to this incident, this event is being reported in an abundance of caution given that devices of this type are associated with the potential complication of adhesions.

• Brand Name: OVITEX LPR
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 20452305
• Report Number: 3010513348-2024-00019
• Device Sequence Number: 8497384
• Product Code: FTM
• UDI-Device Identifier: 09421904065772
• UDI-Public: 09421904065772
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2024
• Report Date (Section F): 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
• 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/24/2024
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/16/2024