MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿ MESH, SURGICAL

Model Number UNK-PERMACOL

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

Patient Problems Death (1802); Necrosis (1971); Sepsis (2067); Multiple Organ Failure (3261)

Event Date 01/19/2019

Event Type  Death  

Manufacturer Narrative

Title: lessons learned from 227 biological meshes used for the surgical treatment of ventral abdominal defects source: article: n. Baldan. 20q8, published online: 19 january 2019 © springer-verlag france sas, part of springer nature 2019. If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, from january 2010 to march 2016, a total of 227 patients whose ventral abdominal defects were reconstructed with a biological mesh were included in the study, and the device was used in 94 of the cases. Patients were divided according to the 2010 four-level surgical-site complication risk grading system proposed by the ventral hernia working group (vhwg): grade 1 (g1, 12 cases), grade 2 (g2, 68 cases), grade 3 (g3, 112 cases), and grade 4 (g4, 35 cases). It was also reported that 11 patients died from the high-risk vhwg group (grades 3 and 4). Death was due to cardiovascular or respiratory complications (3 cases), multiple organ failure (4 cases), sepsis (3 cases), or acute necrotizing pancreatitis (1 case). The types of mesh the patients had implanted were not reported.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9929383
• MDR Text Key: 186575615
• Report Number: 9617613-2020-00048
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNK-PERMACOL
• Device Catalogue Number: UNK-PERMACOL
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/06/2020 Patient Sequence Number: 1