MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC

Model Number	PCO12FX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Chest Pain (1776); Fatigue (1849); Inflammation (1932); Anxiety (2328); Obstruction/Occlusion (2422); Tissue Breakdown (2681); Unintended Radiation Exposure (4565); Pelvic Pain (4865)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter on (b)(6) 2026, post-operative of a laparoscopic suprapubic eventration procedure performed on (b)(6) 2019 where a 12 cm in diameter mesh was implanted, the patient was admitted for acute intestinal obstruction on the small intestine.An exploratory laparoscopy was performed on the same day.The procedure revealed significant epiploic adhesions located directly on the prosthetic plate.Despite the first intervention, the occlusive condition persisted with an ascent of a c-reactive protein (crp) inflammation.A computed tomography (ct) scan performed on (b)(6) 2026 showed the persistence of the intestinal obstruction with junctional syndrome rather in the right iliac fossa.The patient was transferred to another hospital on (b)(6) 2026.Two days later, the patient underwent a major operation by subumbilical median laparotomy.The surgeons then noted incarceration of the small intestine linked to the prosthesis.There were massive adhesions requiring complex adhesiolysis.The prosthesis plate had to be completely removed.A segmental resection of about 3 cm of small intestine at 50 cm from the ileocecal valve with manual latero-lateral anastomosis was done.The patient was discharged on (b)(6) 2026 and since then has had persistent chronic fatigue and debilitating pain when sitting or standing for too long, rendering the patient unable to perform occupational duties.The patient also had to undergo additional ultrasound examinations for persistent bladder and chest pain.The patient also reported suffering psychological trauma and a nxiety.The patient¿s quality of life has been heavily impacted on a daily basis.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25197396
• Report Number: 9615742-2026-00538
• Device Sequence Number: 10110540
• Product Code: FTL
• UDI-Device Identifier: 10884521179738
• UDI-Public: (01)10884521179738(17)230831(10)PSI0588M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: PCO12FX
• Device Catalogue Number: PCO12FX
• Device Lot Number: PSI0588M
• 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: 04/23/2026
• Initial Report FDA Received Date: 05/18/2026
• Date Device Manufactured: 09/26/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female