MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿; MESH, SURGICAL

Model Number P101015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Pain (1994); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191)

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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The pre-op and post-op diagnosis was ventral hernia and morbid obesity.The patient underwent surgical revision of repair of ventral hernia and placement of implant.On (b)(6) 2016 - preoperative diagnosis was incarcerated ventral hernia and high-grade partial small bowel obstruction and post-op diagnosis was incarcerated ventral hernia, the incarceration being greater omentum and dilated proximal small bowel and synthetic mesh, high-grad small bowel obstruction secondary to the second hernia, which was a richter type hernia separate from the large ventral hernia.The procedure performed was reduction and repair of incarcerated ventral hernia with biologic implant and placement of implant, reduction and repair of incarcerated richter hernia which was a separate hernia from the main ventral hernia and it was the cause of the high-grade partial small bowel obstruction and removal of old mesh.On (b)(6) 2017 - the patient underwent a subsequent procedure for incisional hernia repair with mesh and umbilectomy.The pre-op and post-op dia gnosis was incisional hernia and morbid obesity.The patient experienced multiple surgical revisions, lysis of adhesions to previous mesh, recurrence, pain, and bowel obstruction.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incarcerated ventral hernia with biologic implant and placement of implant and the reduction and repair of incarcerated richter hernia.It was reported that after implant, the patient experienced adhesions to previous mesh, recurrence, pain and bowel obstruction.Post-operative patient treatment included revision surgery, lysis of adhesions and recurrence repair.

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.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.Additional information: a1, a4, g4.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: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7402754
• MDR Text Key: 104560339
• Report Number: 9615742-2018-00803
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000115
• UDI-Public: 10884523000115
• Combination Product (y/n): N
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: P101015
• Device Catalogue Number: P101015
• Device Lot Number: AOF0667
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR