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

Model Number LPG1510AR

Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Foreign Body Reaction (1868); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Stenosis (2263); Discomfort (2330); Injury (2348); Diaphoresis (2452); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 right inguinal hernia.It was reported that after implant, the patient experienced pain, mesh wrinkling and mesh migration.Post-operative patient treatment included revision surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced pain, nerve damage, adhesions, mesh wrinkling and mesh migration.Post-operative patient treatment included revision surgery, mesh removal, and neurectomy.

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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced pain, nerve damage, adhesions, mesh wrinkling, foreign body giant cell reaction, meshoma, and mesh migration.Post-operative patient treatment included revision surgery, mesh removal, and neurectomy.

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(meshoma).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

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 right inguinal hernia.It was reported that after implant, the patient experienced pain, nerve damage, adhesions, mesh wrinkling, foreign body giant cell reaction, meshoma, mesh migration, device defective, mental pain, suffering, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included revision surgery, mesh removal, hydrocelectomy and neurectomy.

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 therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced pain, testicle pain, nerve damage, adhesions, mesh wrinkling, foreign body giant cell reaction, meshoma, mesh migration, device defective, mental pain, suffering, disability, impairment, loss of enjoyment of life, mesenteric adenitis, arterial stenosis, abdominal pain, palpable lumps in right groin, night sweats, hydrocele, discomfort, debilitation, bulge of left groin, & scarring.Post-operative patient treatment included medication, revision surgery, mesh removal, hydrocelectomy and triple neurectomy of ilioinguinal; iliohypogastric; genital branch of the genitofemoral nerve, ct scan, ultrasound, iv fluids, partial removal of mesh, exploration right groin, & hernia repair.

Manufacturer Narrative

Additional info: ime e2402: "meshoma, lumps, hydrocele, lymphadenopathy").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 right inguinal hernia.It was reported that after implant, the patient experienced lymphadenopathy, fibrosis, pain, testicle pain, nerve damage, adhesions, mesh wrinkling, foreign body giant cell reaction, meshoma, mesh migration, device defective, mental pain, suffering, disability, impairment, loss of enjoyment of life, mesenteric adenitis, arterial stenosis, abdominal pain, palpable lumps in right groin, night sweats, hydrocele, discomfort, debilitation, bulge of left groin, & scarring.Post-operative patient treatment included jp drain, medication, revision surgery, mesh removal, hydrocelectomy and triple neurectomy of ilioinguinal; iliohypogastric; genital branch of the genitofemoral nerve, ct scan, ultrasound, iv fluids, partial removal of mesh, exploration right groin, & hernia repair.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced pain, testicle pain, nerve damage, adhesions, mesh wrinkling, foreign body giant cell reaction, meshoma, mesh migration, device defective, mental pain, suffering, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included medication, revision surgery, mesh removal, hydrocelectomy and triple neurectomy of ilioinguinal, iliohypogastric, and genital branch of the genitofemoral nerve.Relevant tests/laboratory data (b)(6) 2018: surgical pathology reveal mesh and fibrofatty connective tissue with foreign body giant cell reaction and benign lymphoid tissue.

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 therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced lymphadenopathy, fibrosis, pain, testicle pain, nerve damage, adhesions, mesh wrinkling, foreign body giant cell reaction, meshoma, mesh migration, device defective, mental pain, suffering, disability, impairment, loss of enjoyment of life, mesenteric adenitis, arterial stenosis, abdominal pain, palpable lumps in right groin, night sweats, hydrocele, discomfort, debilitation, bulge of left groin, scarring, decrease in testicular size, testicular atrophy, stabbing pain, & nerve pain.Post-operative patient treatment included jp drain, medication, revision surgery, mesh removal, hydrocelectomy and triple neurectomy of ilioinguinal; iliohypogastric; genital branch of the genitofemoral nerve, ct scan, ultrasound, iv fluids, partial removal of mesh, exploration right groin, hernia repair, & nerve pain medication.

Manufacturer Narrative

Additional info: a1, b5, b7, & h6 ime e2402: testicular atrophy.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 info: h6 (patient codes, ime e2402: psychological adjustment disorder).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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced lymphadenopathy, fibrosis, pain, testicle pain, nerve damage, adhesions, mesh wrinkling, foreign body giant cell reaction, meshoma, mesh migration, device defective, mental pain, suffering, disability, impairment, loss of enjoyment of life, mesenteric adenitis, arterial stenosis, abdominal pain, palpable lumps in right groin, night sweats, hydrocele, discomfort, debilitation, bulge of left groin, scarring, decrease in testicular size, testicular atrophy, stabbing pain, nerve pain, mesenteric lymph nodes, edema, reactive/inflammatory lymph nodes, scar tissue, ilioinguinal neuralgia, neuropathic pain, psychological adjustment disorder.Post-operative patient treatment included jp drain, medication, revision surgery, mesh removal, hydrocelectomy and triple neurectomy of ilioinguinal; iliohypogastric; genital branch of the genitofemoral nerve, ct scan, ultrasound, iv fluids, partial removal of mesh, exploration right groin, hernia repair, nerve pain medication, mri, ultrasound.

• Brand Name: PROGRIP
• 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: 8698138
• MDR Text Key: 147989419
• Report Number: 9615742-2019-02191
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513167
• UDI-Public: 10884521513167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120897
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: LPG1510AR
• Device Catalogue Number: LPG1510AR
• Device Lot Number: PRD0536X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Date Device Manufactured: 04/13/2017
• 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
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White