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

Model Number	VTX1510X3
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Memory Loss/Impairment (1958); Nerve Damage (1979); Pain (1994); Perforation (2001); Scar Tissue (2060); Seroma (2069); Hernia (2240); Anxiety (2328); Distress (2329); Depression (2361); Cognitive Changes (2551); Lethargy (2560); Neuralgia (4413); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced emotional distress.Post-operative patient treatment included revision surgery.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced abscess, recurrence, fistula, infection, nerve damage, pain, suffering, seroma, hematoma, anxiety, depression, tears in bowel, blood in stool, nerve pain, limited mobility, low energy, high blood pressure, body rejecting mesh, scarring, body dysmorphia, fogginess, cognitive impairment, emotional distress.Post-operative patient treatment included revision surgery, abdominal wall exploration, incision and drainage of wound infection, partial mesh removal, negative pressure wound therapy, removal of belly button, and hernia repair with new mesh.
Additional Manufacturer Narrative
Additional info: a2 (date of birth), a3a, b2 (added disability), b5, b7, d1, d4 (model #, catalog #, expiration date, lot #, udi #), g4 (510k #), h4, h6 (patient codes, imf codes, device code).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: h6 (ime e2402: "body dysmorphia").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: VERSATEX
• 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: 22376358
• Report Number: 9615742-2025-00797
• Device Sequence Number: 14562312
• Product Code: FTL
• UDI-Device Identifier: 10884521532625
• UDI-Public: (01)10884521532625(17)270131(10)SWB0823X(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: VTX1510X3
• Device Catalogue Number: VTX1510X3
• Device Lot Number: SWB0823X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 03/04/2026; 03/04/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 03/06/2026; 03/09/2026
• Date Device Manufactured: 02/17/2022
• 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; Disability
• Patient Sex: Male