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

Model Number	TECR1515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Fecal Urgency (4818)
Date of Event	03/17/2017
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, in 2012, the patient underwent a second surgery for recurrence of an inguinal hernia, after a first operation poorly performed.During this second surgery, a mesh was implanted.Following this installation, the health of the patient gradually deteriorated.The patient experienced severe digestive disorders, persistent abdominal pain, food intolerances, chronic fatigue, cognitive disorders, and memory loss.It significantly affected the quality life of the patient.In (b)(6) 2017, a new recurrence of the hernia required a third surgery which is a left groin hernia cure by preperitoneal laparoscopic with placement of prosthesis, with installation of another type of mesh, but with despite this new operation, the symptoms already present have not disappeared, and some worsened over time.The patient¿s social life was almost non-existent, limited to a professional activity made extremely difficult by frequent trips to the toilet, beta-blocker treatment for recurrent migraines.The disorders appeared gradually but are now chronic and very disabling, without improvement despite a rigorous lifestyle and several medical consultations.On the contrary, certain symptoms, particularly digestive and neurological, have become more pronounced.The patient¿s current conditions were severe irritable bowel syndrome, with permanent digestive disorders, disabling chronic fatigue, persistent cognitive impairment, memory loss, general hypersensitivity (intestinal, cutaneous, etc), frequent migraines which requiring treatment with beta-blockers.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22084960
• Report Number: 9615742-2025-00565
• Device Sequence Number: 17874004
• Product Code: FTL
• UDI-Device Identifier: 10884521180291
• UDI-Public: 10884521180291
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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 Expiration Date: 05/31/2022
• Device Model Number: TECR1515
• Device Catalogue Number: TECR1515
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/26/2025
• 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: Other; Required Intervention; Disability
• Patient Sex: Male
• Patient Weight: 75 KG