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

Model Number PCO3020

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Cellulitis (1768); Purulent Discharge (1812); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Seroma (2069); Discharge (2225); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Weight Changes (2607); 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

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.It was reported that after a ventral hernia repair procedure where this device was implanted, the patient experienced infected mesh, chronic sinus tract, and adhesions.The product was used for therapeutic treatment.After the original procedure, additional potentially related procedures were performed, including removal.

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 a procedure where this device was implanted, the patient experienced infected mesh, chronic drainage, fistula, abscess, cellulitis, chronic sinus tract, and adhesions.Post-operative patient treatment included revision surgery, small bowel resection, lysis of adhesions, and removal of mesh.

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 ventral incisional hernia.It was reported that after a procedure where this device was implanted, the patient experienced infected mesh, chronic drainage, fecal and bile drainage, fibrosis, fistula, abscess, cellulitis, chronic sinus tract, irregular thickening in the lower aspect of the left rectus abdominus muscle, inflammation, mesentric lymph nodes, mrsa, fluid collection, seroma, focal thickening sigmoid colon, diverticulitis, neoplasm, tan, yellow, and foul-smelling drainage, extremely emotional, abdominal pain, weight gain, erosion into bowel, and adhesions.Post-operative patient treatment included revision surgery, small bowel resection, lysis of adhesions, medications, admitted to hospital, wound/ostomy care, and removal of mesh.

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: fda site id, mfg site id, a1, a4, a5b, b2, b5, b6, b7, d3 (mfr name, street 1, mfr city, country code, postal code).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.

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 a procedure where this device was implanted, the patient experienced infected mesh, chronic drainage, fecal and bile drainage, fibrosis, fistula, abscess, cellulitis, chronic sinus tract, irregular thickening in the lower aspect of the left rectus abdominus muscle, inflammation, mesentric lymph nodes, mrsa, fluid collection, seroma, focal thickening sigmoid colon, diverticulitis, neoplasm, tan, yellow, and foul-smelling drainage, extremely emotional, abdominal pain, weight gain, erosion into bowel, adhesions, mental pain, pain, injury, disability, impairment, loss of enjoyment of life and defective mesh.Post-operative patient treatment included revision surgery, small bowel resection, lysis of adhesions, medications, admitted to hospital, wound/ostomy care, and removal of mesh.

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 a procedure where this device was implanted, the patient experienced infected mesh, chronic drainage, fecal and bile drainage, fibrosis, fistula, abscess, cellulitis, chronic sinus tract, irregular thickening in the lower aspect of the left rectus abdominus muscle, inflammation, mesenteric lymph nodes, mrsa, fluid collection, seroma, focal thickening sigmoid colon, diverticulitis, neoplasm, tan, yellow, and foul-smelling drainage, extremely emotional, abdominal pain, weight gain, erosion into bowel, adhesions, mental pain, pain, injury, disability, impairment, loss of enjoyment of life and defective mesh.Post-operative patient treatment included revision surgery, small bowel resection, lysis of adhesions, medications, admitted to hospital, wound/ostomy care, debridement, ct-scan, and removal of mesh.Relevant tests/laboratory data: 26 jan 2012: ct scan showed persistent irregular thickening in the lower aspect of the left rectus abdominus muscle.Loops of bowel adjacent to anterior abdominal wall suggestive of adhesions.Small amount of post-inflammatory stranding evident involving sigmoid colon.Multiple enlarged mesenteric lymph nodes.[med a, 16] 31 may 2012: recent biopsy showed mrsa infection in wound.13 aug 2012: ct abdomen/pelvis- continued circumferential short segment thickening of the proximal to mid sigmoid colon.[med a, 32] 12 jun 2013: a1c of 7.4 (poorly controlled diabetes).07 jul 2014: ct abdomen/pelvis showed fat stranding as well as a small fluid collection within the midline of the surgical wound.A small amount of subcutaneous gas noted possibly representing abscess or seroma.[med a, 82] 02 dec 2014: ct abdomen/pelvis showed a possible small postoperative seroma, too small to allow for percutaneous drainage.[med a, 109] 01 apr 2016: ct abdomen/pelvis showed chronic abscess with fistula extending from small bowel through umbilicus and 2 cutaneous tracts along the umbilicus bilaterally.21 nov 2017: ct abdomen/pelvis noted fistulous tract with increased subcutaneous/subfascial fluid and gas collections but remains contained.Focal mural thickening sigmoid colon with peri-colonic fat stranding suggestive of diverticulitis.Findings persistent since apr 2016 raises the possibility of neoplasm.

Manufacturer Narrative

Additional info: b5 <(>&<)> 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.

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 a procedure where this device was implanted, the patient experienced infected mesh, chronic drainage, fecal and bile drainage, fibrosis, fistula, abscess, cellulitis, chronic sinus tract, irregular thickening in the lower aspect of the left rectus abdominus muscle, inflammation, mesentric lymph nodes, mrsa, fluid collection, seroma, focal thickening sigmoid colon, diverticulitis, neoplasm, tan, yellow, and foul-smelling drainage, extremely emotional, abdominal pain, weight gain, erosion into bowel, adhesions, mental pain, pain, injury, disability, impairment, loss of enjoyment of life, defective mesh, mesh prolapsed through fistula tract, <(>&<)> bowel obstruction.Post-operative patient treatment included revision surgery, small bowel resection, lysis of adhesions, medications, admitted to hospital, wound/ostomy care, debridement, ct-scan, removal of mesh, pt, <(>&<)> partial removal of mesh.

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 a procedure where this device was implanted, the patient experienced infected mesh, chronic drainage, fecal and bile drainage, fibrosis, fistula, abscess, cellulitis, chronic sinus tract, irregular thickening in the lower aspect of the left rectus abdominus muscle, inflammation, mesentric lymph nodes, mrsa, fluid collection, seroma, focal thickening sigmoid colon, diverticulitis, neoplasm, tan, yellow, and foul-smelling drainage, extremely emotional, abdominal pain, weight gain, erosion into bowel, adhesions, mental pain, pain, injury, disability, impairment, loss of enjoyment of life, defective mesh, mesh prolapsed through fistula tract.Post-operative patient treatment included revision surgery, small bowel resection, lysis of adhesions, medications, admitted to hospital, wound/ostomy care, debridement, ct-scan, removal of mesh, pt, partial removal of mesh.

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, CO 55112 ; 7635265677
• MDR Report Key: 7477514
• MDR Text Key: 107036591
• Report Number: 9617613-2018-00035
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2014
• Device Model Number: PCO3020
• Device Catalogue Number: PCO3020
• Device Lot Number: PJH00478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2023
• Date Device Manufactured: 09/13/2009
• 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): Hospitalization; Required Intervention; Other; Disability
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White