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

Model Number PCO2520

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Purulent Discharge (1812); Foreign Body Reaction (1868); Granuloma (1876); Hyperplasia (1906); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Impaired Healing (2378); No Code Available (3191); Cancer (3262); Nodule (4551); 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 hernia.It was reported that after implant, the patient experienced (b)(6) 2014: intraperitoneal mesh with omentum densely adhered to mesh, dense adhesions; (b)(6) 2016: adhesions; (b)(6) 2016: office visit for wound and white slough sharply debrided; (b)(6) 2016: open abdominal wall wound, exposed mesh excised, wound care; (b)(6) 2017: wound infection with 'spitting out' of old mesh, slowly granulating wound; (b)(6) 2017: wound continues to contract on abdominal wall; (b)(6) 2017: wound infection with exposure of old mesh, chronic open wound for past 9 months, minimal mesh exposed; (b)(6) 2017: chronic midline wound from exposed mesh, sinuses, wound care; (b)(6) 2017: debridement of abdominal wall, removal of infected mesh.After treatment, the patient experienced multiple revision surgeries.

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 ventral hernia.It was reported that after implant, the patient experienced dense adhesions, open abdominal wound, wound infection with 'spitting out' of old mesh, mesh separated from wall, pelvic mass, purulent fluid, squamous hyperplasia, scar tissue, inflammation, cyst, and colon cancer.Post-operative patient treatment included revision surgery, transverse abdominis plane block, partial right hepatectomy, white slough sharply debrided, exposed mesh excised, wound care, lysis of adhesions, and debridement of abdominal wall.

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.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 hernia.It was reported that after implant, the patient experienced hernia recurrence, pain, non-healing wound, dense adhesions, open abdominal wound, wound infection with 'spitting out' of old mesh, mesh separated from wall, pelvic mass, purulent fluid, squamous hyperplasia, scar tissue, inflammation, cyst, and colon cancer.Post-operative patient treatment included revision surgery, transverse abdominis plane block, partial right hepatectomy, white slough sharply debrided, exposed mesh excised, removal of mesh, wound care, lysis of adhesions, and debridement of abdominal wall.

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.H6:patient code-c64343(pelvic mass).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.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 hernia.It was reported that after implant, the patient experienced dense adhesions, open abdominal wound, wound infection with 'spitting out' of old mesh, mesh separated from wall, pelvic mass, and purulent fluid.Post-operative patient treatment included revision surgery, white slough sharply debrided, exposed mesh excised, wound care, lysis of adhesions, and debridement of abdominal wall.

Manufacturer Narrative

Additional information: b5, b7, g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone) additional 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.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 hernia.It was reported that after implant, the patient experienced hernia recurrence, pain, non-healing wound, dense adhesions, open abdominal wound, wound infection with 'spitting out' of old mesh, mesh separated from wall, pelvic mass, purulent fluid, squamous hyperplasia, scar tissue, inflammation, cyst, and colon cancer.Post-operative patient treatment included revision surgery, transverse abdominis plane block, partial right hepatectomy, white slough sharply debrided, exposed mesh excised, removal of mesh, wound care, lysis of adhesions, medication, and debridement of abdominal wall.Relevant tests/laboratory data: 04 oct 2017: pathology report on abdominal wall revealed benign abdominal wall skin with squamous hyperplasia, scar tissue, acute and chronically inflamed granulation tissue and epidermal inclusion-like cyst.Showed tightly embedded mesh foreign material within the soft tissue.

• 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, CT 55112 ; 7635265677
• MDR Report Key: 7896414
• MDR Text Key: 120960523
• Report Number: 9615742-2018-02161
• 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,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: PCO2520
• Device Catalogue Number: PCO2520
• Device Lot Number: PIH00291
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2022
• 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: UNKNOWN ABSORBATACK (LOT# UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 108 KG