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

Model Number	PCO15X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Necrosis (1971); Scar Tissue (2060); Seroma (2069); Burning Sensation (2146); Hernia (2240); Weight Changes (2607); Unintended Radiation Exposure (4565); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Back pain (4895)
Date of Event	10/14/2025
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
It was reported that mesh round 15 cm polypropylene prosthesis was implanted at the umbilical abdominal wall during a laparoscopic procedure for an umbilical hernia, and that about one month after the operation the patient experienced recurrent umbilical hernia/umbilical recurrence, an eventration orifice noted intraoperatively, chronic unbearable abdominal pain at the navel/prosthesis location (including pain after walking about 100 meters that decreased when lying on the back), back pain, a burning sensation in contact with clothing, necrosis including fat necrosis, scar stigmata with irregularity of the scar path, splenomegaly, weight loss of more than 13 kg, retraction of the navel, and a subumbilical seroma that was extremely sensitive to palpation, with functional impairment including inability to work and being unable to do anything for six and a half months.Moreover, multiple computed tomography scans, ultrasounds, and mris were reported by the patient.An abdominal wall ultrasound performed for pain and palpation of a supraumbilical mass demonstrated a lateralized supraumbilical nodular echogenic infiltration measuring 21 mm x 10 mm with a central fluid image of 9 mm, with no obvious hernia recurrence, and the findings were reported as possibly evoking an infectious process with consideration of follow-up after possible treatment.

• 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: 25404531
• Report Number: 9615742-2026-00602
• Device Sequence Number: 10748734
• Product Code: FTL
• UDI-Device Identifier: 10884521179790
• UDI-Public: (01)10884521179790(17)290131(10)PYB1981M(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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 Model Number: PCO15X
• Device Catalogue Number: PCO15X
• Device Lot Number: PYB1981M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 02/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Unknown