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

Model Number	TEM1208GR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Fever (1858); Headache (1880); Inflammation (1932); Liver Damage/Dysfunction (1954); Rash (2033); Weight Changes (2607)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the cure of a strangulated right inguinal hernia by inguinal approach with mise in place of prosthesis under general anesthesia, the patient experienced the appearance of very large purplish skin rashes all over the body, regular fever (38/39°c), violent abdominal pain that made movement impossible without assistance, inflammation of all lymph nodes, great fatigue, loss of eight kilograms in weight, headaches, and general physical, psychological, and moral exhaustion.Blood tests showed high inflammatory signs, including elevated platelets (414 g/l), fibrinogen (5.25 g/l), c-reactive protein (crp) (35.8 mg/l), triglycerides (1.72 mmol/l), ferritin (2578.0 ¿g/l) , alanine aminotransferase (alt) (82 iu/l), aspartate aminotransferase (ast) (60 iu/l), and lactic acid dehydrogenase (584 iu/l).Liver dysregulation was noted.The patient reported unbearable and disabling pain, itchy skin rashes day and night, loss of autonomy, and loss of employment.Hospitalization lasted for two months, and after returning home at the beginning of (b)(6) 2025, the patient remained unable to resume professional activity.
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.
Additional Manufacturer Narrative
Correction: e1 (prefix, first name, last name), e2, e3 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted rashes are visible on one leg, at thigh level.A scar is also visible in the same area.Functionally, each step of the dhr was found within specifications, particularly the records related to the sterilization and the routine product bioburden and endotoxin monitoring results during the period of the product manufacturing.A search of our global complaints database revealed that this was the only report on file for this lot of product.The reported inflammation and allergic reaction are known potential complications of this type of surgery.It was reported that there was medical complications.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: in chapter "" possible complications "" that "" the possible complications associated with the use of progrip¿ self-gripping polyest er mesh are those typically associated with surgically implantable meshes: hematoma, seroma, infection, acute and chronic pain, extrusion/erosion, inflammation, recurrence, and/or allergic reaction to the components of the product.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: 24255119
• Report Number: 9615742-2026-00107
• Device Sequence Number: 15851326
• Product Code: FTL
• UDI-Device Identifier: 10884521177697
• UDI-Public: (01)10884521177697(17)290331(10)RYD0310X(20)12
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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 Model Number: TEM1208GR
• Device Catalogue Number: TEM1208GR
• Device Lot Number: RYD0310X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/31/2026; 04/08/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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
• Patient Age: 23 YR
• Patient Sex: Male