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

Model Number	PCO4VP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Discomfort (2330); Malaise (2359); Depression (2361); Ambulation or Postural Difficulties (2544); Contact Dermatitis (4546); Unintended Radiation Exposure (4565)
Date of Event	08/01/2021
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
It was reported that an umbilical hernia (reported as 8 mm) was treated with robotic-assisted surgery and implantation of a prosthesis mesh at the navel/umbilical area.Approximately 2 to 3 weeks after the procedure, persistent post-operative pain was reported, and anti-inflammatories were given with an expectation that symptoms would fade over 6 months to 1 year.At approximately 6 months post-procedure, the pain reportedly had not improved, and a radiology evaluation was performed in which the radiologist stated that everything was fine.The patient later returned to the surgeon and was reportedly diagnosed with a painful scar, described as a rare side effect (~5%), and it was stated that the mesh/prosthesis was impossible to remove; injections were offered but were stated to not always work.The patient reported ongoing symptoms for approximately 5 years, including burning sensation at/around the navel, skin sensitivity to clothing/fabrics rubbing the navel area, permanent discomfort at the surgical/implant site, throbbing pain, and pain/sensitivity to touch.Additional impacts included position-related sleep disorder, low mood, difficulty doing sports, difficulty sitting for long periods, and worsened burning sensation for several days/weeks after carrying heavy loads.

• 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: 24991070
• Report Number: 9615742-2026-00464
• Device Sequence Number: 10399228
• Product Code: FTL
• UDI-Device Identifier: 10884521514140
• UDI-Public: (01)10884521514140(17)251231(10)PVA0391X(20)02
• 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: 2021
• 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): 04/24/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: PCO4VP
• Device Catalogue Number: PCO4VP
• Device Lot Number: PVA0391X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 01/13/2021
• 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