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

Model Number	TCM1106X3
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Emotional Changes (1831); Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Seroma (2069); Urinary Retention (2119); Injury (2348); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.He had revision surgery 1 year and 10 months post-surgery.The patient had another revision surgery 2 years and 5 months.The patient experienced chronic and severe pain, multiple removal surgeries, mesh adhesion to nerves, mesh migration and mental anguish.
Additional 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.
Additional 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 or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a sports hernia.It was reported that after implant, the patient experienced chronic and severe pain, scar tissue, genitofemoral neuralgia, nerve damage, adhesions, mesh migration and mental anguish.Post-operative patient treatment included bilateral pelvic floor repairs, revision and removal of mesh surgery.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a sports hernia.It was reported that after implant, the patient experienced defective device, mental pain, scarring, permanent impairment, loss of enjoyment of life, nerve entrapment, inflammation, foreign body reaction, chronic and severe pain, scar tissue, genitofemoral neuralgia, nerve damage, adhesions, mesh migration, and mental anguish.Post-operative patient treatment included bilateral pelvic floor repairs, revision, and removal of mesh surgery.
Additional 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.
Additional 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 or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a sports hernia.It was reported that after implant, the patient experienced defective device, mental pain, scarring, permanent impairment, loss of enjoyment of life, nerve entrapment, inflammation, foreign body reaction, chronic and severe pain, scar tissue, genitofemoral neuralgia, nerve damage, adhesions, mesh migration, seroma, un able to urinate sometimes, and mental anguish.Post-operative patient treatment included mri, exploration, bilateral pelvic floor repairs, revision, medication, and removal of mesh surgery.Relevant tests/laboratory data: 05 nov 2015: pathology report on bone with mesh showed minute fragments of polarizable foreign material with associated foreign body giant cell reaction.12 dec 2016: mri report of pelvis showed severe scarring at pelvic floor/prior mesh repair suture line (left greater than the right).The mesh had been partially removed.Scar tissue impinges on genitofemoral/ilioinguinal/iliohypogastric [sic] nerves (left greater than right).

• Brand Name: PARIETEX
• Common Device Name: 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: 7108049
• Report Number: 9615742-2017-05995
• Device Sequence Number: 1091211
• Product Code: FTL
• UDI-Device Identifier: 10884521178847
• UDI-Public: 10884521178847
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: TCM1106X3
• Device Catalogue Number: TCM1106X3
• Device Lot Number: SNI0238X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 07/03/2019; 07/03/2019; 02/09/2022; 11/08/2023
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 10/08/2019; 11/05/2019; 03/08/2022; 11/10/2023
• Date Device Manufactured: 09/21/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Disability
• Patient Sex: Male
• Patient Weight: 91 KG