MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PCO3020

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 Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Dehydration (1807); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Renal Failure (2041); Staphylococcus Aureus (2058); Sepsis (2067); Vomiting (2144); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Respiratory Failure (2484); Abdominal Distention (2601); Fluid Discharge (2686); 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

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.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 incisional hernia.It was reported that after implant, the patient experienced recurrence, murky drainage from drain, skin dehiscence, draining sinus tract, small chronic abscess cavity, mesh completely detached from fascia, wound dehiscence with evisceration, grossly distended abdomen, drainage from skin incision, bowel nearly protruding through skin incision, light fibrinous inflammatory adhesions, extensive gaseous distended ileus, sepsis, respiratory failure, purulent material in subcutaneous space, fibrinous adhesions, abdominal bloating, nausea, vomiting, non-healing wound on abdomen, bowel obstruction, dehydration, acute renal failure, leukocytosis, staphylococcus aureus/(b)(6), and multiple hospitalizations.Post-operative patient treatment included revision surgeries, lysis of adhesions, exploratory laparotomy, and mesh removal.

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 a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, murky drainage from drain, skin dehiscence, draining sinus tract, small chronic abscess cavity, mesh completely detached from fascia, wound dehiscence with evisceration, grossly distended abdomen, drainage from skin incision, bowel nearly protruding through skin incision, light fibrinous inflammatory adhesions, extensive gaseous distended ileus, sepsis, respiratory failure, purulent material in subcutaneous space, fibrinous adhesions, abdominal bloating, nausea, vomiting, non-healing wound on abdomen, bowel obstruction, dehydration, acute renal failure, leukocytosis, staphylococcus aureus/mrsa, multiple hospitalizations, abdominal pain, mental and physical pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, chronic inflammation, bowel necrosis, fistula, bowel erosion, enterotomy, defective mesh, and failure of mesh.Post-operative patient treatment included revision surgeries, lysis of adhesions, exploratory laparotomy, mesh removal, bowel resection, and bowel serosalization.

Manufacturer Narrative

Additional information: b5, d8, g3, h6 correction: e1(facility name).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 incisional hernia.It was reported that after implant, the patient experienced recurrence, murky drainage from drain, skin dehiscence, draining sinus tract, small chronic abscess cavity, mesh completely detached from fascia, wound dehiscence with evisceration, grossly distended abdomen, drainage from skin incision, bowel nearly protruding through skin incision, light fibrinous inflammatory adhesions, extensive gaseous distended ileus, sepsis, respiratory failure, purulent material in subcutaneous space, fibrinous adhesions, abdominal bloating, nausea, vomiting, non-healing wound on abdomen, bowel obstruction, dehydration, acute renal failure, leukocytosis, staphylococcus aureus/mrsa, multiple hospitalizations, abdominal pain, mental and physical pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, chronic inflammation, bowel necrosis, fistula, bowel erosion, enterotomy, bowel deserosalization, defective mesh, and failure of mesh.Post-operative patient treatment included revision surgeries, lysis of adhesions, exploratory laparotomy, mesh removal, and bowel resection.

Manufacturer Narrative

Additional info: a4, b2 (updated to include life threatening and hospitalization), b5, b7, h4, h6 (patient code, imf codes, ime e2402 updated to include: "ileus, sinus tract").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 incisional hernia.It was reported that after implant, the patient experienced infection, incarceration, recurrence, murky drainage from drain, skin dehiscence, draining sinus tract, small chronic abscess cavity, mesh completely detached from fascia, wound dehiscence with evisceration, grossly distended abdomen, drainage from skin incision, bowel nearly protruding through skin incision, light fibrinous inflammatory adhesions, extensive gaseous distended ileus, sepsis, respiratory failure, purulent material in subcutaneous space, fibrinous adhesions, abdominal bloating, nausea, vomiting, non-healing wound on abdomen, bowel obstruction, dehydration, acute renal failure, leukocytosis, staphylococcus aureus/mrsa, abdominal pain, mental and physical pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, chronic inflammation, bowel necrosis, fistula, bowel erosion, enterotomy, bowel deserosalization, defective mesh, and failure of mesh.Post-operative patient treatment included ct scan, medication, revision surgeries, component separation, bilateral myocutaneous flap, lysis of adhesions, exploratory laparotomy, mesh removal, bowel resection wound vac, hospital admission, and hernia repair with new meshes.

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.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• 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: 9472737
• MDR Text Key: 177179714
• Report Number: 9615742-2019-03865
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• 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,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2013
• Device Model Number: PCO3020
• Device Catalogue Number: PCO3020
• Device Lot Number: PIK00234
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2023
• Date Device Manufactured: 11/15/2008
• 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): Hospitalization; Disability; Required Intervention; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 115 KG