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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 P151520
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); 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.Pre-operative and post-operative diagnosis: unknown.Procedure: unknown.Events: the patient had surgical revision, pain, adhesions, bowel obstruction, fistula, infections, and recurrence.
 
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.
 
Event Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced an unspecified adverse outcome.
 
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: d11-concomitant product: unknown protacker unk; permacol; unk protack.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.
 
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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
MDR Report Key7034663
MDR Text Key92160891
Report Number9617613-2017-05141
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP151520
Device Catalogue NumberP151520
Device Lot Number08B2108
Was Device Available for Evaluation? No
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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