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

Model Number UNKNOWN-PERMACOL

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

Patient Problem Death (1802)

Event Date 01/08/2020

Event Type  Death  

Manufacturer Narrative

Title perioperative complications of complex abdominal wall reconstruction with biologic mesh: a pooled retrospective cohort analysis of 220 patients from two academic centers source international journal of surgery, volume 74, 2020 (94¿99) date of publication: 28 december 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed aimed to identify perioperative predictors of outcomes after complex abdominal wall reconstruction (cawr) with biologic mesh (bm).In this retrospective study, perioperative complications were analyzed in all patients who underwent open cawr with bm over six years in two academic centers.There were 220 patients included in the study and 8 were implanted with the company's complication.8 patient death occurred during the study.The reasons for patient death were not reported.Which mesh was used in the reported adverse events was not reported.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.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: 9889085
• MDR Text Key: 185245923
• Report Number: 9615742-2020-00701
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-PERMACOL
• Device Catalogue Number: UNKNOWN-PERMACOL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR