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U.S. Department of Health and Human Services

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

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TISSUE SCIENCE LABORATORIES MESH TSL - PERMACOL¿ MESH, SURGICAL Back to Search Results
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.
 
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Brand NameMESH TSL - PERMACOL¿
Type of DeviceMESH, 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 Key9929383
MDR Text Key186575615
Report Number9617613-2020-00048
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
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 Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK-PERMACOL
Device Catalogue NumberUNK-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 Received03/17/2020
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
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