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

Model Number	DXT1309AR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Hemorrhage/Blood Loss/Bleeding (1888); Nausea (1970); Abdominal Distention (2601); Unintended Radiation Exposure (4565); Back pain (4895)
Date of Event	08/08/2025
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
According to the reporter, the patient experienced severe and persistent pain occurring continuously during the day and night, resulting in significant functional impairment.The pain led to a substantial decrease in quality of life and inability to perform normal daily activities, including walking, driving, dressing, personal hygiene, and independently getting out of bed.The patient was unable to work and reported difficulty caring for a dependent child due to the condition.The patient reported associated symptoms including significant abdominal swelling and episodes of anal bleeding.Further diagnostic investigations, including a colonoscopy and exploratory fibroscopy, were planned; however, the patient reported physical exhaustion and psychological distress, resulting in postponement of additional invasive procedures.Despite ongoing medical management, including physiotherapy, topical analgesic treatment, opioid pain medication, and antidepressant therapy, the patient reported no improvement.The condition was described as progressively worsening.Additional ongoing symptoms included chronic fatigue, recurrent illness, abdominal distension, nausea, headaches, back pain, and frequent urinary urgency.The overall clinical course was described as prolonged and debilitating, characterized by persistent symptoms and repeated medical consultations without resolution.

• Brand Name: DEXTILE
• 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: 25054832
• Report Number: 9615742-2026-00483
• Device Sequence Number: 13307026
• Product Code: FTL
• UDI-Device Identifier: 10884521726499
• UDI-Public: (01)10884521726499(17)291130(10)SYL0715X(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/01/2026

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: DXT1309AR
• Device Catalogue Number: DXT1309AR
• Device Lot Number: SYL0715X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/01/2026
• Date Device Manufactured: 12/11/2024
• 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: Required Intervention; Disability
• Patient Sex: Unknown