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

Model Number	SYM4232
Medical Device Problem Codes	Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Atrial Fibrillation (1729); Chest Pain (1776); Purulent Discharge (1812); Erythema (1840); Fever (1858); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Necrosis (1971); Perforation (2001); Sepsis (2067); Chills (2191); Discharge (2225); Discomfort (2330); Injury (2348); Ascites (2596); Bowel Perforation (2668); Fibrosis (3167); No Code Available (3191); Constipation (3274)
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 multiple ventral i ncisional hernias.It was reported that after implant, the patient experienced an unspecified adverse outcome.
Additional Manufacturer Narrative
Additional information: g4, h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 laparoscopic treatment of multiple ventral incisional hernias.It was reported that after implant, the patient experienced abdominal pain, fever, chills, chest pain, colitis, sepsis, atrial fibrillation, tenderness, erythema, fascia of poor quality,colonic perforation mesh lying in a large amount of liquid stool, adhesions, mild hypotension postoperatively, necrosis large amount of sanguineous drainage, significant drainage feculent in nature, wound dehiscence, colocutaneous fistula, and constipation.Postoperative patient treatment included wound vac, exploratory laparotomy with extensive lysis of adhesions, mesh extirpation, segmental colostomy with end colostomy, and revision surgery.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9147941
• Report Number: 9615742-2019-03337
• Device Sequence Number: 2802438
• Product Code: FTL
• UDI-Device Identifier: 10884521190603
• UDI-Public: 10884521190603
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2019

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: 12/31/2018
• Device Model Number: SYM4232
• Device Catalogue Number: SYM4232
• Device Lot Number: P0A0380X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 10/16/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/10/2019; 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5950008 VENTRALEX ST HERNIA PATCH (LUQ) (LOT# HUZI
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Weight: 107