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

Model Number	PPM1515X3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Paralysis (1997); Cough (4457)
Date of Event	06/29/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
According to the reporter, the patient had a right diaphragmatic hernia repair via polypropylene mesh in 2023.The patient had pain and affection of breathing directly after.The patient got a nerve conduction study in the same year that showed a right phrenic nerve injury causing partial paralysis of the right phrenic nerve, causing the patient unilateral diaphragmatic paralysis.In (b)(6) 2024, the patient began experiencing a cough with thick green sputum.The culture showed pseudomonas, and it got multiple antibiotics without any improvements.A bronchoscopy with bronchoalveolar lavage and culture showed a staphylococcus pseudintermedius.The patient had antibiotics directed, but no use.It has been a year since the patient got a cough and thick green sputum that is still ongoing daily until this moment.The patient reported that the mesh was infected, and the material was contaminated with an animal, causing a persistent infection.
Additional Manufacturer Narrative
Correction: h6 (additional imf code).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
According to the reporter, the patient had a right diaphragmatic hernia repair via polypropylene mesh in 2023.The patient had pain and affection of breathing directly after.The patient got a nerve conduction study in the same year that showed a right phrenic nerve injury causing partial paralysis of the right phrenic nerve, causing the patient unilateral diaphragmatic paralysis.In (b)(6) 2024, the patient began experiencing a cough with thick green sputum.The culture showed pseudomonas, and it got multiple antibiotics without any improvements.A bronchoscopy with bronchoalveolar lavage and culture showed a staphylococcus pseudintermedius.The patient had antibiotics directed, but no use.It has been a year since the patient got a cough and thick green sputum that is still ongoing daily until this moment.
Additional Manufacturer Narrative
Correction: b5.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: PARIETENE
• 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: 22607939
• Report Number: 9615742-2025-00876
• Device Sequence Number: 9603685
• Product Code: FTL
• UDI-Device Identifier: 10884521213838
• UDI-Public: (01)10884521213838(17)270531(10)SWF1624X(20)02
• Combination Product (Y/N): N
• PMA/510(K) Number: K142091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: PPM1515X3
• Device Catalogue Number: PPM1515X3
• Device Lot Number: SWF1624X
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 08/05/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/07/2025
• Date Device Manufactured: 06/24/2022
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 50 KG