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

Model Number TEM1208GL

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Dyspnea (1816); Edema (1820); Emotional Changes (1831); Inflammation (1932); Ischemia (1942); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Pain (1994); Rash (2033); Hernia (2240); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Weight Changes (2607); No Code Available (3191); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(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 therapeutic treatment of an inguinal hernia.It was reported that after the implant, the patient experienced nerve damage, inguinodynia, nausea, inflammation, loss of appetite, weight loss, adhesions, recurrence, parenchymal edema, ischemic changes, spermatic cord unable to be preserved, and pain/ suffering.Post-operative patient treatment included revision surgery, left orchiectomy, removal of mesh, hernia repair, and left triple neurectomy.

Manufacturer Narrative

Additional information: a4 (weight in lbs).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 an inguinal hernia.It was reported that after the implant, the patient experienced nerve damage, inguinodynia, nausea, inflammation, loss of appetite, weight loss, adhesions, recurrence, parenchymal edema, ischemic changes, spermatic cord unable to be preserved, discomfort, mental pain/anguish, disability, permanent impairment, loss of enjoyment of life, defective mesh, emotional distress, and pain/suffering.Post-operative patient treatment included revision surgery, left orchiectomy, removal of mesh, hernia repair, and left triple 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.

Manufacturer Narrative

Additional information: b5, b7, g1 (manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6 (patient codes).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 an inguinal hernia.It was reported that after the implant, the patient experienced nerve damage, inguinodynia, nausea, inflammation, loss of appetite, weight loss, adhesions, recurrence, parenchymal edema, ischemic changes, spermatic cord unable to be preserved, discomfort, mental pain/anguish, disability, permanent impairment, loss of enjoyment of life, defective mesh, emotional distress, anxiety, and pain/suffering.Post-operative patient treatment included revision surgery, left orchiectomy, removal of mesh, partial mesh removal, hernia repair, loss of testicles, and left triple neurectomy.Relevant tests/laboratory data: on (b)(6) 2019: pathology report on left testicle orchiectomy showed extensive parenchymal edema and early ischemic changes.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an inguinal hernia.It was reported that after the implant, the patient experienced blood culture positive for bacillus species, labs abnormal for hemoglobin, hematocrit and wbc, pulling sensation, numbness, nerve damage, depression, weakness, difficulty sleeping due to pain, inguinodynia, nausea, inflammation, loss of appetite, weight loss, adhesions, recurrence, parenchymal edema, ischemic changes, spermatic cord unable to be preserved, discomfort, mental pain/anguish, disability, permanent impairment, loss of enjoyment of life, defective mesh, emotional distress, anxiety, and pain/suffering.Post-operative patient treatment included nerve block, medication, revision surgery, left orchiectomy, removal of mesh, partial mesh removal, hernia repair, loss of testicles, and left triple neurectomy.

Manufacturer Narrative

Additional info: a4, a5b, b5, b6, b7, h6 (patient codes, imf code, ime e2402: "loss of appetite, abnormal hemoglobin, hematocrit and 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.

Manufacturer Narrative

H6 (patient codes, ime e2402: groin strain).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 an inguinal hernia.It was reported that after the implant, the patient experienced blood culture positive for bacillus species, labs abnormal for hemoglobin, hematocrit and wbc, pulling sensation, thigh/inguinal numbness, nerve damage, depression, weakness, difficulty sleeping due to pain, inguinodynia, nausea, inflammation, loss of appetite, weight loss, adhesions, recurrence, parenchymal edema, ischemic changes, spermatic cord unable to be preserved, discomfort, mental pain/anguish, disability, permanent impairment, loss of enjoyment of life, defective mesh, emotional distress, anxiety, pain/suffering, groin strain, rash, abdominal pain, ambulation difficulties, shortness of breath/dyspnea.Post-operative patient treatment included nerve block, medication, revision surgery, left orchiectomy, removal of mesh, partial mesh removal, hernia repair, loss of testicles, left triple neurectomy, ed visit, pain medication, ct scan, <(>&<)> iv fluid.

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: 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: 10260965
• MDR Text Key: 198435180
• Report Number: 9615742-2020-01584
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177680
• UDI-Public: 10884521177680
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: TEM1208GL
• Device Catalogue Number: TEM1208GL
• Device Lot Number: SQJ0785X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2023
• Date Device Manufactured: 11/03/2016
• 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: 65 KG
• Patient Race: White