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

Model Number	TEM1208GL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Tachycardia (2095); Hernia (2240); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Unspecified Gastrointestinal Problem (4491)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a surgical procedure in (b)(6) 2019 for an umbilical hernia and diastasis, a high eventration occurred, indicating recurrence or new herniation after the initial surgery, and it was alleged that the first prostheses failed.A second operation was performed in (b)(6) 2020 with implantation of mesh.Since these procedures, the individual experienced chronic and very frequent stomach pain, digestion problems, accumulated fatigue, inability to resume sports and normal life, heart problems with tachycardia, suspicion of myocarditis and/or pericarditis, symptoms similar to a heart attack, lung problems, hospitalization, and ongoing monitoring of the lungs.Numerous medical tests were conducted, which revealed no specific findings, and a diagnosis of "long covid" was made.The individual also reported psychological impact and consequences on morale.
Additional Manufacturer Narrative
D10 concomitant products: abstack30x abstack30x abs fixation device30tacks - (lot#n9e1357y); sym2520 sym2520 stex 25x20cm x1 - (lot#ptg2050x); abstack30x abstack30x abs fixation device 30 tacks - (lot#n9e1357y); 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: PROGRIP
• 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: 24637853
• Report Number: 9615742-2026-00322
• Device Sequence Number: 10207633
• Product Code: FTL
• UDI-Device Identifier: 10884521177680
• UDI-Public: (01)10884521177680(17)241031(10)STK1363X
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: TEM1208GL
• Device Catalogue Number: TEM1208GL
• Device Lot Number: STK1363X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 11/20/2019
• 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; Hospitalization
• Patient Sex: Unknown