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

Model Number	PCO8VP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Distress (2329); Discomfort (2330); Ambulation or Postural Difficulties (2544); Unintended Radiation Exposure (4565)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the installation of the anti-hernia mesh, the patient experienced discomfort, background pain, and regularly very intense pain.During episodes of intense pain, the patient was unable to walk or get up, especially when there was a slight difference in altitude.Permanent pain was present since the installation of the anti-hernia net, with stabbing type pain occurring regularly.The pain resulted in an inability to perform daily activities, job loss (the patient had to quit their job as a forester due to inability to work), and the need to leave a seasonal job at times because of pain.The patient ceased all leisure activities, including handball, paragliding, and hiking.The situation caused significant mental distress, with the patient feeling mentally at their lowest and living very badly with permanent pain, as well as feeling abandoned and out of breath.Blood tests were conducted several times, along with ultrasounds, magnetic resonance imaging (mri), and computed tomography (ct) scans.The patient underwent physiotherapy sessions and attended multiple appointments with surgeons and doctors, but was repeatedly told that nothing could be done.
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: 24761129
• Report Number: 9615742-2026-00356
• Device Sequence Number: 10268221
• Product Code: FTL
• UDI-Device Identifier: 10884521514164
• UDI-Public: (01)10884521514164(17)281130(10)PXL1673X(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142908
• 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): 04/01/2026

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: PCO8VP
• Device Catalogue Number: PCO8VP
• Device Lot Number: PXL1673X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 12/20/2023
• 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 Sex: Unknown