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 Code	Pain (1994)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
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, the patient underwent an umbilical hernia surgery by laparoscopy with mesh implant in (b)(6) 2024.During diagnostic laparoscopy.Creation of the pneumoperitoneum by left subcostal puncture.Introduction of optics and two operating trocars in the left flank and in fig.There is indeed a large hernia of the white line with invagination of part of the round ligament.Once the diagnosis is confirmed, the treatment is considered to be carried out laparoscopically.Reduction of the contents by gentle and progressive traction, at the same time as the hernia sac is opened on its left side.Reintegration of the round ligament and the lipoma that remains appended to it in the large peritoneal cavity.The parietal repair is carried out by a circular prolene prosthesis mesh fixed to the posterior surface of the muscle wall by absorbable staples.This prosthesis is separated from the visceral mass by the great omentum.Exsufflation of the peritoneal pno after removal of the instruments and suturing of the skin with staples.Parietal pain on awakening from the operation.This pain has since been treated (by adjustment) with analgesics and will be treated by a pain centre ((b)(6) 2026).On sick leave following the operation.

• 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: 24661552
• Report Number: 9615742-2026-00331
• Device Sequence Number: 12041518
• Product Code: FTL
• UDI-Device Identifier: 10884521179738
• UDI-Public: (01)10884521179738(17)290430(10)PYE0109M(20)10
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PCO12FX
• Device Catalogue Number: PCO12FX
• Device Lot Number: PYE0109M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/23/2026
• Date Device Manufactured: 05/06/2024
• 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
• Patient Age: 41 YR
• Patient Sex: Female