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

Model Number	PCO12FX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Sleep Dysfunction (2517); Ambulation or Postural Difficulties (2544); Tissue Breakdown (2681); Unintended Radiation Exposure (4565)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a ventral hernia repair operation with implantation of a mesh prosthesis was performed, and on the evening of discharge the patient experienced fever, intense ¿electrical stabs¿ pain, and inability to walk.The patient returned the next day and underwent a computed tomography scan, received tramadol for pain management, and was discharged despite ongoing pain.The pain persisted with intense groin and lower abdominal pain and sleep disturbance, and the patient later worsened and was sent to the emergency room where blood tests and computed tomography imaging identified inflammation, infection, and a white liquid under the prosthesis.The patient was hospitalized and treated with amoxicillin, morphine, paracetamol, and acupuncture.The prosthesis was removed and replaced with another prosthesis, after which the pain calmed down and the patient was discharged.Recurrent pain was reported later along with fatigue/exhaustion, and a physician prescribed blood tests and a computed tomography scan to evaluate whether infection and inflammation were still present.The patient also reported loss of trust in the surgeons and alleged inaccurate oral explanations and reports.
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: 24917960
• Report Number: 9615742-2026-00441
• Device Sequence Number: 16057415
• Product Code: FTL
• UDI-Device Identifier: 10884521179738
• UDI-Public: (01)10884521179738(17)291031(10)RYK1555M(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 04/17/2026

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: PCO12FX
• Device Catalogue Number: PCO12FX
• Device Lot Number: RYK1555M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 11/27/2024
• 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: Required Intervention
• Patient Sex: Unknown