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

Model Number	PCO3020OSX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dry Eye(s) (1814); Fatigue (1849); Foreign Body Reaction (1868); Hair Loss (1877); Heartburn/Indigestion (1883); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Blurred Vision (2137); Burning Sensation (2146); Dizziness (2194); Anxiety (2328); Discomfort (2330); Depression (2361); Irritability (2421); Balance Problems (4401); Unspecified Mental, Emotional or Behavioural Problem (4430); Decreased Appetite (4569)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following an open intraperitoneal onlay mesh (ipom) procedure with placement of a mesh prosthesis, the patient experienced a permanent internal burning sensation, pinching sensation, and episodes of violent pain.Since february 2024, the patient reported chronic fatigue, digestive pain, gastric reflux, permanent discomfort in the throat, gastroparesis, early satiety, lack of appetite, chemical body odor, chemical smelly stools, mental fog, anxiety-depressive disorder, difficulty concentrating, irritability, hypertension, tachycardia, difficulty and pain when standing in the abdomen, muscle weakness, balance disorder, dizziness, dark and smelly urine, significant hair loss, dry eyes, and occasional blurred vision.
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
Additional information: g3, 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.

• 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: 24240050
• Report Number: 9615742-2026-00102
• Device Sequence Number: 18387507
• Product Code: FTL
• UDI-Device Identifier: 10884521179776
• UDI-Public: (01)10884521179776(17)281031(10)PXK1694M(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 02/16/2026

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: PCO3020OSX
• Device Catalogue Number: PCO3020OSX
• Device Lot Number: PXK1694M
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 11/22/2023
• 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
• Patient Sex: Unknown