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	Pain (1994); Unintended Radiation Exposure (4565)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer post-operatively on an umbilical procedure, there was pain throughout the abdomen and ribs.The customer went back to the surgeon twice and the surgeon explained that it was the staples that were going to resorb.Six months later, still in pain, then pain where there was the disembowelment.A computed tomography (ct) scan was done, and everything was fine.More than a year later, the customer was still in pain and had not recovered from the previous shape.The patient did have sessions at physiotherapy to remain active and painkillers were taken but doesn't want to get used to it.
Additional Manufacturer Narrative
D10 concomitant products: abstack15, abstack15 abs fixation device 15 tacks (lot#:n3m1865y).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: 22564401
• Report Number: 9615742-2025-00864
• Device Sequence Number: 9237856
• Product Code: FTL
• UDI-Device Identifier: 10884521179776
• UDI-Public: (01)10884521179776(17)241231(10)PUA0563M
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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 Expiration Date: 12/31/2024
• Device Model Number: PCO3020OSX
• Device Catalogue Number: PCO3020OSX
• Device Lot Number: PUA0563M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 01/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female