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

Model Number SYM12

Device Problems Material Erosion (1214); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Erosion (1750); Cyst(s) (1800); Purulent Discharge (1812); Emotional Changes (1831); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Nodule (4551); Unspecified Tissue Injury (4559); 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 therapeutic treatment of a hernia.It was reported that after implant, the patient experienced mesh adhesions to several loops of small bowel, serosal injury to bowel requiring suture repair; ascites in various quadrants along with a gelatinous mucin-like material in the lower abdomen, recurrent bulge near umbilicus, discomfort, cystic appendiceal mass, mucinous fluid throughout abdomen.Post-operative patient treatment included revision surgery.Relevant tests/laboratory data: (b)(6) 2018 ct scan of abdomen/pelvis showed perihepatic fluid tracking along the right paracolic gutter and extending to and above the abdominal wall mesh, questionable hernia recurrence, and mass of unknown origin with partial wall calcification in lower abdomen.

Manufacturer Narrative

This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 therapeutic treatment of a ventral type umbilical hernia.It was reported that after implant, the patient experienced mesh adhesions to several loops of small bowel, serosal injury to bowel requiring suture repair; ascites in various quadrants along with a gelatinous mucin-like material in the lower abdomen, recurrent bulge near umbilicus, discomfort, cystic appendiceal mass, mucinous fluid throughout abdomen, and mesh erosion into viscera.Post-operative patient treatment included revision surgery, laparoscopic adhesiolysis, sampling of intraabdominal fluid, and resection of abdominal mass with the appendix.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral type umbilical hernia.It was reported that after implant, the patient experienced mesh adhesions to several loops of small bowel, serosal injury to bowel requiring suture repair; ascites in various quadrants along with a gelatinous mucin-like material in the lower abdomen, recurrent bulge near umbilicus, discomfort, cystic appendiceal mass, mucinous fluid throughout abdomen, mesh erosion into viscera, physical deformity, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, perihepatic fluid tracking to and above mesh, foreign body reaction and inflammatory reaction.Post-operative patient treatment included revision surgery, laparoscopic adhesiolysis, sampling of intraabdominal fluid, serosal injury suture repair, specimen sent to pathology and resection of abdominal mass with the appendix.

Manufacturer Narrative

Additional info: b2 (disability), b5, d8, e1 (facility name, street 1, city, region, postal code), g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, country code, postal code, email, phone number), g3, g4 (pma/510k).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.

Manufacturer Narrative

Additional info: h6 (patient code, imf codes).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 therapeutic treatment of a ventral type umbilical hernia.It was reported that after implant, the patient experienced obstruction, mesh adhesions to several loops of small bowel, serosal injury to bowel requiring suture repair; ascites in various quadrants along with a gelatinous mucin-like material in the lower abdomen, recurrent bulge near umbilicus, discomfort, cystic appendiceal mass, mucinous fluid throughout abdomen, mesh erosion into viscera, physical deformity, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, perihepatic fluid tracking to and above mesh, foreign body reaction and inflammatory reaction.Post-operative patient treatment included removal of mesh, hernia repair with new mesh, medication, revision surgery, laparoscopic adhesiolysis, sampling of intraabdominal fluid, serosal injury suture repair, specimen sent to pathology and resection of abdominal mass with the appendix.

• 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: 8461206
• MDR Text Key: 140204175
• Report Number: 9615742-2019-00804
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190344
• UDI-Public: 10884521190344
• 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,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: SYM12
• Device Catalogue Number: SYM12
• Device Lot Number: POG0516X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2023
• Date Device Manufactured: 08/02/2014
• 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
• Patient Sex: Male
• Patient Weight: 100 KG