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

Model Number	TECT1612AR
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Emotional Changes (1831); Pain (1994); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative was bilateral inguinal hernia and the postoperative diagnosis was left direct inguinal hernia and right indirect inguinal hernia.The patient underwent a diagnostic laparoscopy and laparoscopic inguinal hernia repair with mesh utilizing tep approach.The patient experienced revision/removal surgery and hernia recurrence.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem 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 implant, the patient experienced adhesions, mesh shrinkage/contracture, failure of mesh, hernia recurrence, mental pain, pain, suffering, device defective, disability, impairment, loss of enjoyment of life, and loss of care/comfort/consortium.Post-operative patient treatment included revision surgery, medication, partial mesh removal, and hernia repair with new meshes.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic treatment of an bilateral inguinal hernia.It was reported that after implant, the patient experienced adhesions, mesh shrinkage/contracture, failure of mesh, hernia recurrence, mental pain, pain, suffering, device defective, disability, impairment, loss of enjoyment of life, <(>&<)> mesh rolled upon itself.Post-operative patient treatment included revision surgery, medication, partial mesh removal, hernia repair with new meshes, hospitalization, iv pain medication, <(>&<)> mesh revision.

• Brand Name: PARIETEX
• Common Device Name: 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 ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 6877040
• Report Number: 9615742-2017-05290
• Device Sequence Number: 1312155
• Product Code: FTL
• UDI-Device Identifier: 10884521179967
• UDI-Public: 10884521179967
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: TECT1612AR
• Device Catalogue Number: TECT1612AR
• Device Lot Number: SNI0942X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 04/24/2024; 12/18/2024
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 04/29/2024; 01/15/2025
• Date Device Manufactured: 10/05/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABSORBATACK TACKERS
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White