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

Model Number	PCO3020OSX
Medical Device Problem Codes	Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Sepsis (2067); Hernia (2240); Injury (2348); Impaired Healing (2378); Bowel Perforation (2668); No Code Available (3191); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of hernia.It was reported that after implant, the patient experienced extensive lysis of adhesions, small bowel resection, anastomosis of longstanding enterocutaneous fistula and excision of previous mesh with placement of new mesh.The device had been used with wound vac.Post-operative patient treatment included revision surgery.
Additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of complex incisional hernia and a left-sided parastomal hernia.It was reported that after implant, the patient experienced extensive lysis of adhesions, small bowel resection, anastomosis of longstanding enterocutaneous fistula and excision of previous mesh with placement of new mesh.The device had been used with wound vac.Post-operative patient treatment included revision surgery.
Additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of hernia.It was reported that after implant, the patient experienced extensive lysis of adhesions, small bowel resection, anastomosis of longstanding e nterocutaneous fistula and excision of previous mesh with placement of new mesh.The device had been used with wound vac.Post-operative patient treatment included revision surgery.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of complex incisional hernia and a left-sided parastomal hernia.It was reported that after implant, the patient experienced fistula and adhesions.Post-operative patient treatment included extensive lysis of adhesions, small bowel resection, anastomosis of longstanding enterocutaneous fistula, wound vac and excision of previous mesh with placement of new mesh.
Additional 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.
Additional 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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of complex incisional hernia and a left-sided parastomal hernia.It was reported that after implant, the patient experienced fistula, foreign body type granulomatous reaction, and adhesions.Post-operative patient treatment included extensive lysis of adhesions, small bowel resection, anastomosis of longstanding enterocutaneous fistula, wound vac and excision of previous mesh with placement of new mesh.The device was used with prolene mesh (lot #: eab223, product id: pml).
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of complex incisional hernia and a left-sided parastomal hernia.It was reported that after implant, the patient experienced fistula, foreign body type granulomatous reaction, pain, mesh erosion, bowel perforation, and adhesions.Post-operative patient treatment included extensive lysis of adhesions, small bowel resection, anastomosis of longstanding enterocutaneous fistula, wound vac, long term iv antibiotics, and excision of previous mesh with placement of new mesh.
Additional 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.
Additional Manufacturer Narrative
Additional info: b2, b5, b7, g1, g3, h6 (added patient 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.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 or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of complex incisional hernia and a left-sided parastomal hernia.It was reported that after implant, the patient experienced infection, recurrence, inflammation, abscess, sepsis, chronic open abdominal wound, fistula, foreign body type granulomatous reaction, pain, mesh erosion, bowel perforation, and adhesions.Post-operative patient treatment included medication, use of tpn, pic line, gastronomy tube, icu stay, use of drains, removal of umbilicus, blood and platelet transfusion, extensive lysis of adhesions, small bowel resection, anastomosis of longstanding enterocutaneous fistula, wound vac, long term iv antibiotics, and excision of previous mesh with placement of new mesh.
Additional 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: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• Common Device Name: 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: 8465051
• Report Number: 9615742-2019-00849
• Device Sequence Number: 19154544
• Product Code: FTL
• UDI-Device Identifier: 10884521179776
• UDI-Public: 10884521179776
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/03/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: PCO3020OSX
• Device Catalogue Number: PCO3020OSX
• Device Lot Number: PMJ00635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/03/2019; 04/17/2019; 05/15/2019; 05/15/2019; 11/10/2021; 12/21/2022; 12/18/2024
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/05/2019; 05/08/2019; 11/04/2019; 11/14/2019; 12/01/2021; 12/21/2022; 01/03/2025
• Date Device Manufactured: 11/10/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROLENE MESH (LOT #: EAB223, PRODUCT ID: PML)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG