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

Model Number	TEC1515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Hernia (2240); Shaking/Tremors (2515)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following the placement of a mesh during a cure of eventration procedure in the right iliac fossa, a swelling appeared in the right pit after significant efforts.Ultrasound confirmed eventration with a 2cm neck.Pain was associated with the eventration, and there was a clinical concern regarding the risk of strangulation.Over the course of several months, the patient's condition deteriorated, resulting in walking difficulties, a feeling of heaviness and diffuse pain in the stomach, tingling in the limbs, tremors, and weakness in the legs.There was an allegation of a deleterious effect due to diffusion of toxic toxins from the implanted material.Clinical examination was performed at entry and remained unchanged since the last consultation.
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.
Additional Manufacturer Narrative
Correction: d6a (implanted date), g3 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.
Additional Manufacturer Narrative
Correction: a2, b5, h6 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 following the placement of a mesh during a procedure for cure of eventration in the right iliac fossa, wherein eventration with a two-centimeter neck was confirmed by ultrasound.Over the course of several months, the patient's condition deteriorated, resulting in walking difficulties, a feeling of heaviness and diffuse pain in the stomach, tingling in the limbs, tremors, and weakness in the legs.The surgeon noted there could be a deleterious effect due to diffusion of toxic toxins from the implantedmaterial.

• 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: 24638325
• Report Number: 9615742-2026-00324
• Device Sequence Number: 13302066
• Product Code: FTL
• UDI-Device Identifier: 10884521180260
• UDI-Public: (01)10884521180260(17)241031(10)STK1656M
• 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: 2020
• 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,Followup,Followup
• Report Date (Section B): 05/14/2026

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 Expiration Date: 10/31/2024
• Device Model Number: TEC1515
• Device Catalogue Number: TEC1515
• Device Lot Number: STK1656M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 05/14/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/08/2026; 05/14/2026
• Date Device Manufactured: 11/23/2019
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 53 KG