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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 P100055
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Atrial Fibrillation (1729); Hypoxia (1918); Unspecified Infection (1930); Nausea (1970); Scarring (2061); Vomiting (2144); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Abdominal Distention (2601); No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
According to the reporter, the patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent the implantation of a permacol mesh due to a hernia.
 
Event Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, draining sinus, bulging, abscess, adhesions, infection, nausea, vomiting, abdominal discomfort, ileus obstruction, eschar scar, cholecystitis/cholelithiasis, hypoxia, and intermittent atrial fibrillation.Post-operative patient treatment included small bowel resection, lysis of adhesions, implantation of new mesh, full thickness fascia amputation, significant oxygen therapy, placed on continuous anti-arrhythmic and continuous anticoagulant, oral anticoagulant and oral anti-arrhythmic, and cholecystectomy.The device had been used with concomitantly with a perfix 4.1 x 4.8 cm mesh for repair of a right inguinal hernia.
 
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.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.
 
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.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.
 
Event Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence abscess, adhesions and infection.Post-operative patient treatment included small bowel resection, lysis of adhesions and implantation of new mesh.The device had been used with concomitantly with a perfix 4.1 x 4.8 cm mesh for repair of a right inguinal hernia.On (b)(4) 2014 - revision, recurrent incisional hernia repaired with strattice 10 x 10 cm mesh.On (b)(4) 2018 ¿ revision with strattice 20 x 30 cm strattice 10 x 16 cm.
 
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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 Key6868510
MDR Text Key86331939
Report Number9617613-2017-05112
Device Sequence Number1
Product Code FTM
UDI-Device Identifier10884523000047
UDI-Public10884523000047
Combination Product (y/n)N
PMA/PMN Number
K992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2015
Device Model NumberP100055
Device Catalogue NumberP100055
Device Lot Number11B1306
Was Device Available for Evaluation? No
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PERFIX 4.1 X 4.8 CM MESH (LOT# UNKNOWN)
Patient Outcome(s) Other; Required Intervention;
Patient Age73 YR
Patient Weight82
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