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	Pain (1994); Hernia (2240); Unintended Radiation Exposure (4565)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the clinical study, postoperative to a left inguinal hernia repair, the patient had repetitive and intense pain.Medications such as doliprane, tramadol, gabapentin, versatis patch, pregabalin, laroxyl, cymbalta, oramorph, and amitriptyline were ineffective.On (b)(6) 2025, the patient was hospitalized for a left inguinal hernia and old prosthesis excision using the lichtenstein technique.The immediate post-operative follow-up was simple with resumption of a normal, well-tolerated diet, according to the protocol of improved rehabilitation after surgery.The scars were clean and non-inflammatory.Given the favorable development, the patient was allowed to return home the same day.Patient followed at the pain center for placement of a qutenza patch.The patient underwent an ultrasound, a computed tomography (ct) scan and an electromyopgraphy (emg).There was no recurrence, and no nerve damage.The patient had an intolerance without effective treatments with an altered quality of life.The patient was then scheduled for a removal of the plaque under general anesthesia and a wall closure by suture.There was no hernia, yet there was a small lipoma in the superficial inguinal orifice which was resected.
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.

• 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: 24827797
• Report Number: 9615742-2026-00392
• Device Sequence Number: 18718411
• Product Code: FTL
• UDI-Device Identifier: 10884521177680
• UDI-Public: (01)10884521177680(17)290228(10)SYC0817X(20)10
• 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: 2024
• Device Explanted Year: 2025
• 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): 04/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TEM1208GL
• Device Catalogue Number: TEM1208GL
• Device Lot Number: SYC0817X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 03/13/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown