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

Model Number LPG1510

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Unspecified Tissue Injury (4559); 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 defective mesh, mental pain, scarring, permanent impairment, loss of enjoyment of life, pain, inflammation, adhesions, and mesh migration.Post-operative patient treatment included intervention surgery.

Manufacturer Narrative

Additional information: a2, a3, b5, b7, d4 (model#, catalogue, implant date, explant date), d8, g1 (manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), g4 (510k), 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 a right inguinal hernia.It was reported that after implant, the patient experienced defective mesh, mental pain, scarring, permanent impairment, loss of enjoyment of life, pain, inflammation, adhesions, suffering, nerve damage, foreign body giant cell response, and mesh migration.Post-operative patient treatment included intervention surgery, iloinguinal neuropathy, resection of inguinal nerve, and mesh removal.

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 right ilioinguinal neuropathy, nerve entrapment, scrotal pain, mesh buckling, loss of tissue planes, nonvascular tubular structure in inguinal soft tissues, bilateral hydroceles, defective mesh, mental pain, scarring, permanent impairment, loss of enjoyment of life, pain, inflammation, adhesions, suffering, nerve damage, foreign body giant cell response, and mesh migration.Post-operative patient treatment included application of hemp oil, surgery for right ileal inguinal neuropathic pain, exploration of rlq division of right ilioinguinal nerve, ultrasound guided injection to right ilioinguinal nerve, pain medication, laparoscopy, nerve resection, spermatic cord block, lumbar spine injection, procedure for right inguinal neuropathy, use of antibiotics, opioid therapy for right inguinal pain, ct scan, ultrasound, intervention surgery, iloinguinal neuropathy, resection of inguinal nerve, and mesh removal.

Manufacturer Narrative

Additional info: h6 (patient codes, device code, imf codes, ime e2402: "bilateral hydroceles, nonvascular tubular structure, loss of tissue planes, nerve entrapment").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.

• Brand Name: UNKNOWN PROGRIP MESH PRODUCT
• 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: 14283207
• MDR Text Key: 290794054
• Report Number: 9615742-2022-00423
• Device Sequence Number: 1
• Product Code: FTL
• 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
• Report Date: 02/27/2023

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
• Device Operator: Health Professional
• Device Model Number: LPG1510
• Device Catalogue Number: LPG1510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 02/01/2023; 02/15/2023
• Supplement Dates FDA Received: 02/08/2023; 02/27/2023
• 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: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American