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

Model Number TECT1510AL

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Erythema (1840); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Ascites (2596); Bowel Perforation (2668); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was not - available, no op report.The procedure performed was the patient underwent left inguinal hernia repair, laparoscopic, with mesh.Other relevant history: claimant has had a infection; adhesion; mesh contraction; bowel perforation; bladder perforation resulting in tumor in bladder; revision surgery; surgery to remove 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.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 a bilateral inguinal hernias.It was reported that after implant, the patient experienced infection, adhesions, mesh contraction, bowel perforation, bladder perforation resulting in tumor in bladder, high grade dysplasia, inflammation, erythema, induration, pocket of fluid, mesh floating freely, scar tissue, significant pain in right groin, and hypertrophic granulation tissue.Post-operative patient treatment included revision surgery, lap excision of inguinal hernia mesh, removal of mesh, cystourethroscopy, cystectomy, take down of adhesions, bladder dissected free, and multiple medications.

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.Product was used for laparoscopic therapeutic treatment of a bilateral inguinal hernias.It was reported that after implant, the patient experienced infection, adhesions, mesh contraction, bowel perforation, bladder perforation resulting in tumor in bladder, inflammation, erythema, induration, pocket of fluid, mesh floating freely, and scar tissue.Post-operative patient treatment included revision surgery, removal of mesh, cystourethroscopy, cystectomy, take down of adhesions, and bladder dissected free.

Manufacturer Narrative

Additional information: b2, b5, d8, e1 (facility name, street 1, city, region, postal code), g1, g3, h6 h6 patient codes - c64343 (dysplasia; induration).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 a bilateral inguinal hernias.It was reported that after implant, the patient experienced infection, adhesions, mesh contraction, bowel perforation, bladder perforation resulting in tumor in bladder, high grade dysplasia, inflammation, erythema, induration, pocket of fluid, scar tissue, significant pain in right groin, hypertrophic granulation tissue, mental pain, pain/suffering, device defective, mesh failure, disability, impairment, loss of enjoyment of life, hernia recurrence, mesh migration.Post-operative patient treatment included revision surgery, lap excision of inguinal hernia mesh, removal of mesh, cystourethroscopy, cystectomy, take down of adhesions, bladder dissected free, and multiple medications.

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 a bilateral inguinal hernias.It was reported that after implant, the patient experienced infection, adhesions, mesh contraction, bowel perforation, bladder perforation resulting in tumor in bladder, high grade dysplasia, inflammation, erythema, induration, pocket of fluid, scar tissue, significant pain in right groin, hypertrophic granulation tissue, mental pain, pain/suffering, device defective, mesh failure, disability, impairment, loss of enjoyment of life, hernia recurrence, hematoma, allergic reaction, decreased ability for activities, mesh migration.Post-operative patient treatment included revision surgery, lap excision of inguinal hernia mesh, removal of mesh, cystourethroscopy, cystectomy, take down of adhesions, bladder dissected free, and multiple medications.Relevant tests/lab data: 15sep2014: per op note, bladder mass biopsied found to be consistent with high-grade dysplasia, continued to be present, concern for malignancy vs possible inflammatory change from bladder, involvement of hernia mesh.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 6887298
• MDR Text Key: 87155787
• Report Number: 9615742-2017-05345
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: TECT1510AL
• Device Catalogue Number: TECT1510AL
• Device Lot Number: SIJ00292
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2023
• Date Device Manufactured: 10/13/2008
• 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: ABSTACK20(LOT#: N9C0812); TECT1510AR ANAT RT STD PY 15X10CM (LOT#:SJA00119)
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White