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

Model Number TEC1515

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Gangrene (1873); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191); 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 bilateral inguinal hernia and umbilical hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, chronic drainage, abscess, colocutaneous fistula, and rectosigmoid inflammation.Post-operative patient treatment included bowel resection and mesh removal.

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.Additional information: patient code-c64343(crohn's disease).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 bilateral inguinal hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, recurrence, open wound, chronic drainage, infection, abscess, colocutaneous fistula, rectosigmoid inflammation, crohn¿s disease and ischemic, gangrenous, perforated splenic flexure.Post-operative patient treatment included bowel resection and removal of infected mesh, lysis of adhesions, repair of recurrent hernia with phasix mesh, wound vac, exploratory laparotomy, and colon resection with ileocolotomy.

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 bilateral inguinal hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, recurrence, open wound, chronic drainage, infection, abscess, colocutaneous fistula, and rectosigmoid inflammation.Post-operative patient treatment included bowel resection and removal of infected mesh, repair of recurrent hernia with phasix mesh, wound vac, exploratory laparotomy, ileocolic resection, ileostomy and hartman's pouch.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a bilateral inguinal hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, recurrence, open wound, chronic drainage, infection, abscess, colocutaneous fistula, rectosigmoid inflammation, crohn¿s disease and ischemic, gangrenous, perforated splenic flexure, and pain.Post-operative patient treatment included bowel resection and removal of infected mesh, lysis of adhesions, repair of recurrent hernia with phasix mesh, wound vac, exploratory laparotomy, and colon resection with ileocolotomy.

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 a bilateral inguinal hernia.It was reported that after implant, the patient experienced extensive adhesions between small bowel and mesh, recurrence, open wound, chronic drainage, infection, abscess, colocutaneous fistula, rectosigmoid inflammation, crohn¿s disease and ischemic, gangrenous, perforated splenic flexure, and pain.Post-operative patient treatment included bowel resection and removal of infected mesh, lysis of adhesions, repair of recurrent hernia with phasix mesh, wound vac, exploratory laparotomy, medication, and colon resection with ileocolotomy.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PARIETEX
• 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: 8396706
• MDR Text Key: 138023744
• Report Number: 9615742-2019-00408
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180260
• UDI-Public: 10884521180260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: TEC1515
• Device Catalogue Number: TEC1515
• Device Lot Number: SKL00388
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019; 12/15/2021; 02/07/2024; 05/08/2024
• Supplement Dates FDA Received: 10/01/2019; 12/09/2019; 01/03/2022; 02/13/2024; 05/15/2024
• Date Device Manufactured: 12/25/2010
• 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
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White