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

Model Number PCO20X

Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205); 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); Erosion (1750); Cellulitis (1768); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Abdominal Distention (2601); Bowel Perforation (2668); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.­­­­­­­­­the procedure performed was intra abdominal lysis of adhesions laparoscopic.The patient has had multiple surgical revisions, infections, small bowel obstructions, adhesions, intestinal perforation, and recurrence.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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.Product was used for laparoscopic therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced recurrence, infections, small bowel obstruction, adhesions, and intestinal perforation.Post-operative patient treatment included revision surgery, lysis of adhesions, exploratory laparotomy,and ventral hernia repair.

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.Product was used for laparoscopic therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced recurrence, infections, small bowel obstruction, adhesions, and intestinal perforation.Post-operative patient treatment included revision surgery, lysis of adhesions, exploratory laparotomy,and ventral hernia repair.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced mesh migration, unincorporated mesh that pulled forward, mesh erosion, intestinal perforation, persistent wound drainage, recurrence, pain, infection, abscess, small bowel obstruction, and adhesions.Post-operative patient treatment included revision surgery, lysis of adhesions, exploratory laparotomy, and ventral hernia repair.

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.Product was used for laparoscopic therapeutic treatment of an umbilical hernia.It was reported that after implant, the patient experienced mesh migration, unincorporated mesh that pulled forward, mesh erosion, intestinal perforation, persistent wound drainage, recurrence, pain, infection, abscess, small bowel obstruction, adhesions, dislodged mesh, inflammation, cellulitis.Post-operative patient treatment included revision surgery, lysis of adhesions, exploratory laparotomy, ventral hernia repair with mesh, partial explant of mesh, 12 days of hospitalization, use of blake drain, medication.

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.Product was used for laparoscopic therapeutic treatment of an ventral hernia.It was reported that after implant, the patient experienced mesh migration, unincorporated mesh that pulled forward, mesh erosion, intestinal perforation, persistent wound drainage, recurrence, pain, infection, abscess, small bowel obstruction, adhesions, dislodged mesh, inflammation, cellulitis, diastases of the rectus muscles, abdominal pain, bulging, & bloody drainage from incision.Post-operative patient treatment included revision surgery, lysis of adhesions, exploratory laparotomy, ventral hernia repair with mesh, partial explant of mesh, 12 days of hospitalization, use of blake drain, medication, & ct scan.

Manufacturer Narrative

Additional info: a5a, a5b, b5, b6, b7, & h6 (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.

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

Additional information: a4.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: 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 ; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 7176693
• MDR Text Key: 96807940
• Report Number: 9615742-2018-00106
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179677
• UDI-Public: 10884521179677
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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: 11/04/2022

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: 09/30/2019
• Device Model Number: PCO20X
• Device Catalogue Number: PCO20X
• Device Lot Number: POI0791X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 05/15/2019; 05/15/2019; 02/09/2022; 03/16/2022; 09/28/2022; 10/26/2022; 10/26/2022; 10/26/2022
• Supplement Dates FDA Received: 10/28/2019; 12/26/2019; 03/09/2022; 04/06/2022; 10/11/2022; 11/01/2022; 11/01/2022; 11/04/2022
• Date Device Manufactured: 10/04/2014
• 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: UNKABSTACK(LOT#: UNKNOWN)
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American