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

Model Number SYM2015

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Anemia (1706); Purulent Discharge (1812); Emotional Changes (1831); Fever (1858); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Tachycardia (2095); Vomiting (2144); Electrolyte Imbalance (2196); Hernia (2240); Anxiety (2328); Depression (2361); Ascites (2596); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); 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 an umbilical hernia.It was reported that after implant, the patient experienced mental pain, pain, impairment, loss of enjoyment of life, scarring, infection, recurrence, necrosis, abscess, inflammation, adhesions, defective mesh, failure of mesh, mesh migration.Post-operative patient treatment included revision surgery, mesh revision, hernia repair with new mesh, debrided necrotic tissue/wound, abdomen washed out, some fatty tissue was removed, wound irrigated, wound vac.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced muscle spasms, nausea, vomiting, abdominal pain with walking, mental pain, pain, impairment, loss of enjoyment of life, scarring, infection, recurrence, necrosis, abscess, inflammation, adhesions, defective mesh, failure of mesh, mesh migration.Post-operative patient treatment included medication, exploratory laparotomy, revision surgery, mesh revision, explant of infected mesh, lysis of adhesions, re-exploration of open abdomen, incisional drainage of subcutaneous abscess, irrigation of abdominal wound, partial closure of midline wound, debridement of skin and soft tissues and application of negative pressure therapy wound vac, hernia repair with new mesh, debrided necrotic tissue/wound, abdomen washed out, and some fatty tissue was removed.

Manufacturer Narrative

Additional info: a2 (date of birth), d4 (expiration date, lot #), h6 (added patient codes, added imf codes, removed imf code).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: a1, a4, b5, b6, b7, d10, h6 (patient codes, imf codes, ime e2402: "fibrofatty tissue").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 umbilical hernia.It was reported that after implant, the patient experienced fluid collection, polymicrobial infection, fibrofatty tissue, fever, purulent discharge, tachycardia, electrolyte imbalance, pus, transient hypotensive episode, fibrinous exudate, anxiety, depression,anemia, bleeding, deserosalization, muscle spasms, nausea, vomiting, abdominal pain with walking, mental pain, pain, impairment, loss of enjoyment of life, scarring, infection, recurrence, necrosis, abscess, inflammation, adhesions, defective mesh, failure of mesh, mesh migration.Post-operative patient treatment included use of jp drains, ct scan, antibiotics, hospitalization and subsequent icu admission, iv antibiotics, iv pain and antinausea medications, iv fluids, electrolyte replacement, drain placement, medication, exploratory laparotomy, revision surgery, mesh revision, explant of infected mesh, lysis of adhesions, partial omentectomy, re-exploration of open abdomen, incisional drainage of subcutaneous abscess, peritoneocentesis, intraoperatively received 2 units of rbc and 1200 of crystalloid, removal of tacks, irrigation of abdominal wound, partial closure of midline wound, fascial closure, wound packing, wound vac change under anesthesia, debridement of skin and soft tissues and application of negative pressure therapy wound vac, hernia repair with new mesh, pt/ot, debrided necrotic tissue/wound, abdomen washed out, and some fatty tissue was removed.

Manufacturer Narrative

Correction: b2: (added hospitalization).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.

• 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: 14117971
• MDR Text Key: 289329488
• Report Number: 9615742-2022-00329
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: SYM2015
• Device Catalogue Number: SYM2015
• Device Lot Number: PSK0458X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Date Device Manufactured: 11/24/2018
• 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
• Treatment: SECURESTRAP 5MM.
• Patient Outcome(s): Disability; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 59 KG