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

Model Number	PCO2H4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Laceration(s) (1946)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, postoperatively of an esophageal hiatal hernia, fixation was performed using the mesh.The following day, the patient reported acute abdominal pain (epigastric pain).After a ct scan, an emergency laparotomy was performed, during which the mesh was completely removed.After the mesh removal, an intra-abdominal observation revealed that the symptoms were not caused by the mesh.However, the cause of the pain remains undetermined.The incision range had exceeded 1 inch, the surgical time was extended by more than 30 minutes, and since the procedure turned into an open mesh removal, the hospitalization period was expected to be extended by one to two weeks.
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.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20241096
• Report Number: 9615742-2024-01337
• Device Sequence Number: 8637677
• Product Code: FTL
• UDI-Device Identifier: 10884521178472
• UDI-Public: 10884521178472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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
• Report Date (Section B): 09/17/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: PCO2H4
• Device Catalogue Number: PCO2H4
• Device Lot Number: YXK2183M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/17/2024
• Date Device Manufactured: 11/29/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown