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

Model Number	SYM8OS
Medical Device Problem Codes	Material Erosion (1214); Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Scar Tissue (2060); Injury (2348); Weight Changes (2607); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
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 incarcerated incisional ventral hernia.It was reported that after implant, the patient experienced infection, drainage, fistula, erosion, severe pain, loss of appetite and weight loss.The device had been used with ventralex hernia mesh 5950007, lot# huya1210.Post-operative patient treatment included surgical revision.The patient has ongoing medical issues including the need for future medical treatment.
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 incarcerated incisional ventral hernia.It was reported that after implant, the patient experienced infection, drainage, fistula, erosion, severe pain, loss of appetite, inflammation, bowel injury, adhesions, mesh migration, failure of mesh, scarring, mental pain, permanent impairment, loss of enjoyment of life, defective mesh, and weight loss.Post-operative patient treatment included surgical revision, resection of fistula, cecal vault repair, mesh intervention surgery, and resection of infected mesh.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: a4, b5, 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 incarcerated incisional ventral hernia.It was reported that after implant, the patient experienced infection, drainage, fistula, erosion, severe pain, loss of appetite, inflammation, bowel injury, adhesions, mesh migration, failure of mesh, scarring, mental pain, permanent impairment, loss of enjoyment of life, defective mesh, perforation, and weight loss.Post-operative patient treatment included surgical revision, resection of fistula, cecal vault repair, mesh revision surgery, and hernia repair with new mesh.Concomitant device: ventralex hernia mesh 5950007, lot# huya1210.

• 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: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 8123215
• Report Number: 9615742-2018-02639
• Device Sequence Number: 16206103
• Product Code: FTL
• UDI-Device Identifier: 10884521190627
• UDI-Public: 10884521190627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/24/2024

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: SYM8OS
• Device Catalogue Number: SYM8OS
• Device Lot Number: PNL0142X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/30/2019; 11/06/2019; 02/09/2022; 07/17/2024
• Initial Report FDA Received Date: 12/02/2018
• Supplement Report FDA Received Date: 01/16/2020; 03/05/2020; 03/09/2022; 07/24/2024
• Date Device Manufactured: 11/30/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VENTRALEX HERNIA MESH 5950007(LOT# HUYA1210)
• Outcome Attributed to Adverse Event: Required Intervention; Other; Disability
• Patient Sex: Male
• Patient Weight: 78 KG