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

Model Number SYM2015

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Chest Pain (1776); Purulent Discharge (1812); Dyspnea (1816); Erythema (1840); Fever (1858); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Necrosis (1971); Pain (1994); Pneumonia (2011); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Chills (2191); Dizziness (2194); Hernia (2240); Distress (2329); Discomfort (2330); Obstruction/Occlusion (2422); Diaphoresis (2452); Sleep Dysfunction (2517); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Sexual Dysfunction (4510); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic treatment of a abdominal hernia.It was reported that after implant, the patient experienced adhesions, bowel obstruction, hernia recurrence, pain, bowel problems, and bowel involvement.Post-operative patient treatment included revision surgery, and mesh removal surgery.

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.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 Description

The patient¿s attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic treatment of a abdominal hernia.It was reported that after implant, the patient experienced necrotic tissue, hard mass, inflammation, drainage, seroma, abscess, mesh shrinkage, adhesions, bowel obstruction, hernia recurrence, pain, bowel problems, and bowel involvement.Post-operative patient treatment included revision surgery, mesh removal surgery, and hernia repair with new mesh.

Manufacturer Narrative

Additional info: b2 (added hospitalization and disability), d4 (expiration date, lot#), h6 (patient codes, imf codes, ime e2402: "fibroadipose tissue, fibrohistiocytic reaction, gas collection, right heart strain, citrobacter koseria, acinetobacter baumannii, abnormal troponin, bnp, and d-dimer, diastolic dysfunction, elevated rsvp, serratia marcescens, pseudomonas aeruginosa, thrombophlebitis, unable to have sex, induration, uncontrolled blood sugars, mass").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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic laparoscopic treatment of an incisional hernia.It was reported that after implant, the patient experienced fibroadipose tissue, fibrohistiocytic reaction, giant cells, gas collection, growth of citrobacter koseria and acinetobacter baumannii complex, right heart strain, abnormal troponin, bnp, and d-dimer, diastolic dysfunction, elevated rsvp, growth of serratia marcescens and pseudomonas aeruginosa, thrombophlebitis, nausea, sleep disturbances, discomfort, swelling, abdominal pain, phlegmon, ascites, scarring, fibrosis, embolism, blood clot, pneumonia, thrombosis, staphylococcus aureus, disability, shortness of breath, fever, chills, redness, purulent discharge, sweating, infection, cellulitis, distention, vomiting, weakness, acute distress, chest pain, unable to work, distention, blood loss, green discharge, brownish fluid output, creamy drainage, swelling, unable to have sex due to pain, induration, discomfort, tenderness, weakness, dizziness, hemorrhage, uncontrolled blood sugar, diastasis, necrotic tissue, hard mass, inflammation, drainage, seroma, abscess, mesh shrinkage, adhesions, bowel obstruction, hernia recurrence, pain, bowel problems, and bowel involvement.Post-operative patient treatment included ct scan, ultrasound, jp drains, pca pump, physical therapy, iv fluids, medication, supplemental oxygen, home health services, procedure for fluid collection, catheter exchange under fluoroscopic guidance, home oxygen, anticoagulation treatment, use of keflex, iv antibiotics, pain medication, wound care, wearing abdominal binder, wound washout, betadine soaked packing, hospitalization, diagnostic laparoscopy, revision surgery, mesh removal surgery, and hernia repair with new mesh.

• Brand Name: SYMBOTEX
• Type of Device: 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: 11858172
• MDR Text Key: 251980471
• Report Number: 9615742-2021-01322
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190450
• UDI-Public: 10884521190450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: SYM2015
• Device Catalogue Number: SYM2015
• Device Lot Number: PSK0824
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2023
• Date Device Manufactured: 12/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Sex: Male
• Patient Weight: 52 KG
• Patient Ethnicity: Hispanic