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

Model Number SYM12

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Diarrhea (1811); Purulent Discharge (1812); Emotional Changes (1831); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Seroma (2069); Hernia (2240); Injury (2348); Abdominal Distention (2601); Weight Changes (2607); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product: sym2015 stex 20 x 15cm x1, (product id: sym2015, lot #: pqd0959x).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 an incisional hernia.It was reported that after the implant, the patient experienced abscess, infection, infected mesh, adhesions, recurrence, nausea, diarrhea, inflammation, loss of appetite, extreme weight loss, staph, serosal tears, bulge, abscess, purulent material, mesh floating, lack of mesh incorporation, necrosis, ischemia, fibrinous debris, abdominal wall appeared fibrinous and pale, and pain/ suffering.Post-operative patient treatment included revision surgeries, hernia repair with new mesh, serosal tears repaired, partial removal of mesh, removal of some staples, placement of drains, drainage of abscess, debridement of soft tissue/ skin/ subcutaneous tissue/ muscle of abdominal wall wound, wound vac, washout of subcutaneous space, necrotic debridement, antibiotics, excised few pale ischemic areas of subcutaneous fat, and lysis of adhesions.

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 therapeutic treatment of an incisional ventral hernia.It was reported that after the implant, the patient experienced defective device, mental pain, impairment, loss of enjoyment of life, scarring, seromas, abscess, infection, infected mesh, adhesions, recurrence, nausea, diarrhea, inflammation, loss of appetite, extreme weight loss, staph, serosal tears, bulge, abscess, purulent material, mesh floating, lack of mesh incorporation, necrosis, ischemia, fibrinous debris, abdominal wall appeared fibrinous and pale, and pain/suffering.Post-operative patient treatment included revision surgeries, hernia repair with new mesh, serosal tears repaired, partial removal of mesh, removal of some staples, placement of drains, drainage of abscess, debridement of soft tissue/skin/subcutaneous tissue/muscle of abdominal wall wound, wound vac, washout of subcutaneous space, necrotic debridement, antibiotics, excised few pale ischemic areas of subcutaneous fat, and lysis of adhesions.

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.

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 therapeutic treatment of an incisional ventral hernia.It was reported that after the implant, the patient experienced suture granuloma, necrotic granulation tissue, defective device, mental pain, impairment, loss of enjoyment of life, scarring, seromas, abscess, infection, infected mesh, adhesions, recurrence, nausea, diarrhea, inflammation, loss of appetite, extreme weight loss, staph, serosal tears, bulge, purulent material, mesh floating, lack of mesh incorporation, necrosis, ischemia, fibrinous debris, abdominal wall appeared fibrinous and pale, and pain/suffering.Post-operative patient treatment included medication, imaging, exploratory laparotomy, resection of mesh, release of small bowel obstruction, sharp excision of tissue, dressing changes and repacking, exploration and removal of suture granuloma and necrotic granulation tissue, revision surgeries, hernia repair with new mesh, serosal tears repaired, partial removal of mesh, removal of some staples, placement of drains, drainage of abscess, debridement of soft tissue/skin/subcutaneous tissue/muscle of abdominal wall wound, wound vac, washout of subcutaneous space, necrotic debridement, antibiotics, excised few pale ischemic areas of subcutaneous fat, and lysis of adhesions.

• 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, CT 55112 ; 7635265677
• MDR Report Key: 10260907
• MDR Text Key: 198436444
• Report Number: 9615742-2020-01582
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYM12
• Device Catalogue Number: SYM12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2023
• 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
• Treatment: SEE SECTION H10..
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Male
• Patient Weight: 113 KG