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

Model Number PCO15

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Fever (1858); Nausea (1970); Necrosis (1971); Pain (1994); Perforation (2001); Tachycardia (2095); Vomiting (2144); Chills (2191); Discharge (2225); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); 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 parastomal hernia.It was reported that after implant, the patient experienced chronic pain, multiple small bowel obstructions, multiple abscesses, adhesions and recurrence.The device had been used with a baxbio fibrin tisseel frozen 4ml device (ref# (b)(4), lot# vnd4l045).Post-operative patient treatment included mesh explant and multiple surgical revisions ((b)(6) 2013, (b)(6) 2016, (b)(6) 2017).

Manufacturer Narrative

Additional information: concomitant device: baxbio fibrin tisseel frozen 4ml device (ref# 1501262, lot# vnd4l045); unk protack(lot#; unknown) patient code-c64343(leukocytosis).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 laparoscopic therapeutic treatment of a parastomal hernia.It was reported that after implant, the patient experienced chronic pain, multiple small bowel obstructions, multiple abscesses, adhesions, abdominal pain, fever, chills, nausea, vomiting, tachycardia, leukocytosis, necrosis, ascites, small perforation, minor enteric spillage, and recurrence.Post-operative patient treatment included mesh explant, lysis of adhesions, excision of mesh and tacks, reduction of peristomal hernia, hernia repair with mesh, enterorrhaphy, long tube decompression of small bowel, and multiple surgical revisions.The device had been used with a baxbio fibrin tisseel frozen 4ml device (ref# 1501262, lot# vnd4l045).

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a parastomal hernia.It was reported that after implant, the patient experienced multiple small bowel obstructions, multiple abscesses, adhesions, abdominal pain, fever, chills, nausea, vomiting, tachycardia, leukocytosis, necrosis, ascites, small perforation, minor enteric spillage, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and recurrence.Post-operative patient treatment included mesh explant, lysis of adhesions, excision of mesh and tacks, reduction of peristomal hernia, hernia repair with mesh, enterorrhaphy, long tube decompression of small bowel, and multiple surgical revisions.

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 laparoscopic therapeutic treatment of a parastomal hernia.It was reported that after implant, the patient experienced multiple small bowel obstructions, multiple abscesses, adhesions, abdominal pain, fever, chills, nausea, vomiting, tachycardia, leukocytosis, necrosis, ascites, small perforation, minor enteric spillage, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and recurrence.Post-operative patient treatment included mesh explant, lysis of adhesions, excision of mesh and tacks, reduction of peristomal hernia, hernia repair with mesh, enterorrhaphy, long tube decompression of small bowel, multiple surgical revisions, ct scan.

• 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 ; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8287658
• MDR Text Key: 134438832
• Report Number: 9615742-2019-00189
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2023

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: 11/30/2014
• Device Model Number: PCO15
• Device Catalogue Number: PCO15
• Device Lot Number: PJL00248
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 11/06/2019; 01/26/2022; 11/15/2023
• Supplement Dates FDA Received: 11/25/2019; 02/10/2022; 11/29/2023
• Date Device Manufactured: 12/19/2009
• 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): Disability; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White