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

Model Number	TECR1510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Fatigue (1849); Hearing Impairment (1881); Inflammation (1932); Pain (1994); Twitching (2172); Distress (2329); Discomfort (2330); Paresthesia (4421)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an individual underwent inguinal hernia surgery with implantation of a mesh, the individual reported abnormal persistent pain to the surgeon immediately post-operation, and in the days and weeks after surgery the pain gradually became lasting, described as tightness, local discomfort, and chronic persistent daily pain with more intense episodes depending on movement or activity.The individual also reported new symptoms not present before the procedure, including paresthesia in the hands and legs and fasciculations affecting different body areas including the face and limbs.Additional disorders were reported after the surgery, including a thymic cyst that was being explored, episodes of lacrimal gland inflammation predominantly on the left side, hearing disorders, and physical fatigue.The ongoing symptoms were reported to limit personal activities and reduce activity level, with psychological impact related to persistence and lack of understanding of symptoms, including a relationship break-up and psychoanalytic follow-up.The condition was reported as stabilized with persistent chronic pain.
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.

• 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: 25096183
• Report Number: 9615742-2026-00506
• Device Sequence Number: 17413080
• Product Code: FTL
• UDI-Device Identifier: 10884521180284
• UDI-Public: (01)10884521180284(17)270131(10)SWB0837M(20)02
• 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: 2022
• 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): 05/06/2026

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: TECR1510
• Device Catalogue Number: TECR1510
• Device Lot Number: SWB0837M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/06/2026
• Date Device Manufactured: 02/17/2022
• 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 Sex: Unknown