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 Adhesion(s) (1695); Cyst(s) (1800); Emotional Changes (1831); Granuloma (1876); Muscle Spasm(s) (1966); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Scarring (2061); Swelling (2091); Hernia (2240); Discomfort (2330); Injury (2348); Numbness (2415); No Code Available (3191); Cramp(s) /Muscle Spasm(s) (4521); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: (lot# sie00074).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 therapeutic treatment of a bilateral inguinal hernia.After implant, the patient experienced intractable debilitating inguinodynia, injury of vas deferens due to adhesions to mesh, adhesions of mesh to veins, nerve damage, and hernia recurrence.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of a bilateral inguinal hernia.It was reported that after the implant, the patient experienced intractable debilitating inguinodynia, injury of vas deferens due to adhesions to mesh, adhesions of mesh to veins, nerve damage, and hernia recurrence.Post-operative patient treatment included revision surgery and excision 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.

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.Patient code(b)(6) ( epididymitis, pididymal head lesion, tumor, pea sized lump on testis).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 a bilateral inguinal hernia.It was reported that after the implant, the patient experienced intractable debilitating inguinodynia, injury of vas deferens due to adhesions to mesh, adhesions, scarring, nerve damage, cyst, epididymitis, pididymal head lesion, tumor, granuloma, pain, swelling, pea sized lump on testis, back spasms, numbness, tenderness, and hernia recurrence.Post-operative patient treatment included revision surgery, injected marcaine and iidocaine for pain relief, vas deferens amputation, and excision 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 a bilateral inguinal hernia.It was reported that after the implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, intractable debilitating inguinodynia, injury of vas deferens due to adhesions to mesh, adhesions, scarring, nerve damage, cyst, varicocele, epididymitis, epididymal head lesion, tumor, granuloma, pain, swelling, pea sized lump on testis, back spasms, numbness, tenderness, and hernia recurrence.Post-operative patient treatment included revision surgery, injected marcaine and iidocaine for pain relief, vas deferens amputation, and excision 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 a bilateral inguinal hernia.It was reported that after the implant, the patient experienced mental pain, disability, impairment, loss of enjoyment of life, defective mesh, intractable debilitating inguinodynia, injury of vas deferens due to adhesions to mesh, adhesions, scarring, nerve damage, cyst, varicocele, epididymitis, epididymal head lesion, tumor, granuloma, pain, swelling, pea sized lump on testis, back spasms, numbness, tenderness, and hernia recurrence.Post-operative patient treatment included revision surgery, injected marcaine and iidocaine for pain relief, vas deferens amputation, ct-scan, ultrasound, acupuncture, and excision of mesh.Relevant tests/laboratory data: (b)(6) 2012: ultrasound of scrotum/testicles showed small left varicocele in close proximity to area of symptomatic complaint, left epididymal cyst.(b)(6) 2012: ct abdomen/pelvis showed prior inguinal hernia repairs with mesh.Small bilateral indirect inguinal hernias containing fat only.(b)(6) 2014: ct abdomen/pelvis showed recurrent incarcerated bilateral inguinal hernias containing fat only.(b)(6) 2015: ultrasound of scrotum and testicles showed enlarged, hyperemic epididymal heads suggesting bilateral epididymitis.Evidence of recurrent right inguinal hernia (b)(6) 2015: ultrasound of scrotum and testicles showed left sided varicocele, right epididymal head lesion.Possibilities would include a benign adenomatoid tumor or granuloma.Left epididymal head cyst.

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: 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: 9340356
• MDR Text Key: 166938674
• Report Number: 9615742-2019-03770
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: TECR1510
• Device Catalogue Number: TECR1510
• Device Lot Number: SIE00074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2023
• Date Device Manufactured: 05/14/2008
• 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: TECR1510 PARIETEX RIGID PY 15X10CM X1; UNKABSTACK(LOT#: UNKNOWN); TECR1510 PARIETEX RIGID PY 15X10CM X1
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White