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

Model Number	PCO8VP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Unintended Radiation Exposure (4565)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
References: successful non-operative mesh salvage using a multi-modal treatment strategy for infected composite mesh amy aimei jiang, joel lau, wei keat cheah, man hon tang year:2024, the author(s) doi.Org/10.1007/s10029-024-03017-9.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the literature, an obese 60-year-old gentleman underwent emergency surgery for port site hernia and bowel obstruction, which developed three days following laparoscopic small bowel resection.A composite ventral patch 8.6 cm was placed in the intra-peritoneal layer due to a 4 cm fascial defect.The patient presented to the emergency department with pain, fever, and abnormal laboratory values and underwent computed tomography (ct), which showed an extensive infection surrounding the mesh.Urgent percutaneous drainage and intravenous antibiotics were required, followed by dilution and washout of the cavity with large volumes of saline solution.A ct scan performed at the end of the treatment confirmed resolution of the infection, and the patient remained well.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20905940
• Report Number: 9615742-2024-01682
• Device Sequence Number: 4223144
• Product Code: FTL
• UDI-Device Identifier: 10884521165724
• UDI-Public: 10884521165724
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K142908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: PCO8VP
• Device Catalogue Number: PCO8VP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 12/11/2024
• 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 Age: 60 YR
• Patient Sex: Male