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

Model Number	SYM2515E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Perforation (2001); Seroma (2069); Distress (2329); Injury (2348); Fluid Discharge (2686); Nodule (4551); Unspecified Tissue Injury (4559)
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 fistula, infection and dense adhesions of small bowel to the mesh.Post-operative patient treatment included small bowel resection and mesh removal surgery.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration or any association with this device.
Additional Manufacturer Narrative
Additional info: b5, d8, e1 (street 1, city, region, postal code), g1, h6 (patient codes), & additional codes.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 an incisional hernia.It was reported that after implant, the patient experienced fistula, infection, dense adhesions of small bowel to the mesh, emotional distress, & death.Post-operative patient treatment included small bowel resection, mesh removal surgery, & surgical intervention.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration or any association with this device.
Additional Manufacturer Narrative
Additional information: b2, b5, b7, h6 (patient codes, device codes), and additional codes.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 an incisional hernia.It was reported that after implant, the patient experienced fistula, infection, dense adhesions of small bowel to the mesh, emotional distress, seroma, abscess, mass, bowel/intestinal perforation, pain, suffering, general inhibition of walking and mobility, serous fluid, enterotomies, necrosis, and death.Post-operative patient treatment included small bowel resection, mesh revision, mesh removal surgery, surgical intervention, wound exploration, exploratory lap, lysis of adhesions, excision of abdominal mass, closure of colostomy, diverting ileostomy, end ileostomy, placement of wound vac, closure of small bowel fistula, and negative pressure wound therapy.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration or any association with this device.
Additional Manufacturer Narrative
Correction: added h6 (patient 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.

• Brand Name: SYMBOTEX
• 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, CT 55112-4391 ; 8006464633
• MDR Report Key: 9450784
• Report Number: 9615742-2019-03829
• Device Sequence Number: 11535810
• Product Code: FTL
• UDI-Device Identifier: 10884521190474
• UDI-Public: 10884521190474
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• 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,Followup
• Report Date (Section B): 03/20/2026

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 Expiration Date: 10/31/2016
• Device Model Number: SYM2515E
• Device Catalogue Number: SYM2515E
• Device Lot Number: PNJ0969X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 10/01/2025; 03/04/2026; 03/18/2026
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 10/07/2025; 03/12/2026; 03/20/2026
• Date Device Manufactured: 11/14/2013
• 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: Disability; Required Intervention; Death
• Patient Age: 55 YR
• Patient Sex: Male