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

Model Number	TECT1510AR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Discomfort (2330); Unintended Radiation Exposure (4565)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following surgery for bilateral inguinal hernias with implantation of two mesh, the patient experienced constant pain that could not be relieved, persistent moderate to severe pain on both sides radiating to the testicles, tension, tightness, burning sensations, inability to sit for long periods, inability to carry a small load, inability to wear a belt, and inability to hold back urination.The pain was described as unbearable, requiring emergency room visits, and resulted in a significant reduction in activities, impacting family and social life.Ongoing pain management included a neuropathic pain agent, a tricyclic antidepressant, an anxiolytic (benzodiazepine), and transcutaneous electrical nerve stimulation (tens) therapy.Multiple surgeons refused to re-operate.Several ultrasounds, scans, mris (magnetic resonance imagine scans), and blood tests were conducted, all showing no abnormality.
Additional Manufacturer Narrative
D10 concomitant product: tect1510al, tect1510al anat lt std py 15x10cm, (lot # sxg0124m).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.

• 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: 24551400
• Report Number: 9615742-2026-00270
• Device Sequence Number: 15799180
• Product Code: FTL
• UDI-Device Identifier: 10884521180017
• UDI-Public: (01)10884521180017(17)290430(10)SYE1212M(20)10
• Combination Product (Y/N): N
• PMA/510(K) Number: K982532
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: TECT1510AR
• Device Catalogue Number: TECT1510AR
• Device Lot Number: SYE1212M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/09/2026
• Date Device Manufactured: 05/22/2024
• 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: Other
• Patient Sex: Unknown