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

Model Number TECR1510

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

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Emotional Changes (1831); Fistula (1862); Impotence (1925); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Skin Discoloration (2074); Ulceration (2116); Discharge (2225); Ulcer (2274); Discomfort (2330); Injury (2348); Depression (2361); Disability (2371); Impaired Healing (2378); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Sexual Dysfunction (4510); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.(b)(4).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 bilateral inguinal hernias.It was reported that after the implant, the patient experienced sharp pains, infected mesh, intestinal blockage, open wound, discomfort in pelvic, hip, and groin area, inability to lift leg without use of hands and to get in a vehicle, "felt like a brillo pad was breaking up into pieces under the surface of my skin", 4-5 noticeable lumps under the skin, inability to get dressed without pain, depression, inability to have sex, lumps turned into one big bulge extending from the hip area and the other in the groin area, bulge turned purple, red, and black, scar tissue, bulge leaked in two different areas, inability to play with their kids, and noticeable slow down in work performance.Post-operative patient treatment included a cat scan, prescribed antibiotics and pain medicine for a month, wound vac, 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: a1, a4, a5b, b5, b6, b7, d11, g4, h6 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 bilateral inguinal hernias.It was reported that after the implant, the patient experienced sharp pains, infected mesh, intestinal blockage, open wound, discomfort in pelvic, hip, and groin area, inability to lift leg without use of hands and to get in a vehicle, "felt like a brillo pad was breaking up into pieces under the surface of my skin", 4-5 noticeable lumps under the skin, inability to get dressed without pain, depression, inability to have sex, lumps turned into one big bulge extending from the hip area and the other in the groin area, bulge turned purple, red, and black, scar tissue, bulge leaked in two different areas, inability to play with their kids, ulcer, inflammation, staphylococcus aureus, small bowel obstruction, adhesions, drainage, ulceration, cellulitis, and noticeable slow down in work performance.Post-operative patient treatment included a cat scan, prescribed antibiotics and pain medicine for a month, wound vac, lysis of adhesions, release of small bowel obstruction, antibiotics, 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 laparoscopic therapeutic treatment of bilateral inguinal hernias.It was reported that after the implant, the patient experienced infected mesh, intestinal blockage, open wound, discomfort in pelvic, hip, and groin area, inability to lift leg without use of hands and to get in a vehicle, "felt like a brillo pad was breaking up into pieces under the surface of my skin", 4-5 noticeable lumps under the skin, inability to get dressed without pain, depression, inability to have sex, lumps turned into one big bulge extending from the hip area and the other in the groin area, bulge turned purple, red, and black, scar tissue, bulge leaked in two different areas, inability to play with their kids, ulcer, inflammation, staphylococcus aureus, small bowel obstruction, adhesions, drainage, ulceration, cellulitis, pain, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and noticeable slow down in work performance.Post-operative patient treatment included a cat scan, prescribed antibiotics and pain medicine for a month, wound vac, lysis of adhesions, release of small bowel obstruction, antibiotics, and removal of mesh.

Manufacturer Narrative

Additional information: g3 corrected information: h6 patient codes - e2402 (lumps).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

Additional information: b5, g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6(patient codes), no code e2402: non-healing sinus, abnormal wbc.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 bilateral inguinal hernias.It was reported that after the implant, the patient experienced infected mesh, intestinal blockage, open wound, discomfort in pelvic, hip, and groin area, inability to lift leg without use of hands and to get in a vehicle, "felt like a brillo pad was breaking up into pieces under the surface of my skin", 4-5 noticeable lumps under the skin, inability to get dressed without pain, depression, inability to have sex, lumps turned into one big bulge extending from the hip area and the other in the groin area, bulge turned purple, red, and black, scar tissue, bulge leaked in two different areas, inability to play with their kids, ulcer, inflammation, staphylococcus aureus, small bowel obstruction, adhesions, drainage, ulceration, cellulitis, pain, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, abnormal wbc, non-healing sinus formation in left inguinal hernia area, abscess, fistula, and noticeable slow down in work performance.Post-operative patient treatment included a cat scan, prescribed antibiotics and pain medicine for a month, wound vac, wound therapy, lysis of adhesions, release of small bowel obstruction, antibiotics, debridement, exploratory laparotomy, and removal of mesh.Relevant tests/laboratory data: (b)(6) 2013: abnormal wbc 14.9, (b)(6) 2017: pathology report on soft tissue of inguinal region showed skin and subcutis with ulcer, inflammation, and scar.(b)(6) 2017: abnormal lab values of wbc 12.4, hgb 10.9, hct 33.2 (b)(6) 2017: microbiology report showed moderate growth of staphylococcus aureus.(b)(6) 2018: pathology report on nonhealing left inguinal wound excision showed skin and subcutaneous tissue with focal acute and chronic inflammation and reactive changes.

• 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: 9502727
• MDR Text Key: 177183186
• Report Number: 9615742-2019-03895
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180284
• UDI-Public: 10884521180284
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: TECR1510
• Device Catalogue Number: TECR1510
• Device Lot Number: SMF00624
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2023
• Date Device Manufactured: 07/07/2012
• 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: TECR1510(LOT#: SMJ00794).; UNKABSTACK(LOT#: UNKNOWN).
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: Black Or African American