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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 P151828
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Scarring (2061); Seroma (2069); Hernia (2240); Injury (2348); Ascites (2596); Abdominal Distention (2601); 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.The product was used for therapeutic treatment of a hernia.It was reported that after a procedure where this device was implanted, the patient experienced mesh failure; recurrence; infection; seroma; adhesion removal.After treatment, the patient experienced revision.
 
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: (udi#), corrected information: (product code, common device name), (model#, catalog#, expiration date).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 laparoscopic treatment of an incisional hernia.It was reported that after a procedure where this device was implanted, the patient experienced mesh failure, hernia recurrence, infection, seroma, right lower quadrant abdominal wall abscess, chronic scarring, abdominal wall deformity, benign lesion, bulging and abdominal pain, groin pain, abdominal wall fluid collection, and adhesions.Post-operative treatment included revision surgery, incision/drainage/debridement of the seroma cavity, placement of a wound vac, three additional placements of new mesh during repairs of incisional/inguinal/ventral hernias, panniculectomy, implant of pain pump, wound drainage, incision and unroofing of abscess, excision of lesion, and adhesion removal.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic laparoscopic treatment of an incisional hernia.It was reported that after a procedure where this device was implanted, the patient experienced mesh failure, hernia recurrence, infection, seroma, and adhesions.Post-operative treatment included revision surgery and adhesion removal.Received medical records additionally show that after implant, the patient experienced a recurring seroma, incisional hernia recurrence, right lower quadrant abdominal wall abscess, chronic scarring, inguinal hernia with groin pain, ventral hernia with bulging and abdominal pain, a benign lesion, and abdominal wall deformity.Treatment included incision/drainage/debridement of the seroma cavity, placement of a wound vac, three additional placements of new mesh during repairs of incisional/inguinal/ventral hernias, panniculectomy, implant of pain pump, and excision of lesion.
 
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: b5, b6, b7, d3(mfr name, street1, mfr city, country code, postal code), e4(email), g4, h6 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.Additional information: a5b, b5, b6, g4.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 an incisional hernia.It was reported that after a procedure where this device was implanted, the patient experienced mesh failure, hernia recurrence, infection, seroma, right lower quadrant abdominal wall abscess, chronic scarring, abdominal wall deformity, benign lesion, bulging and abdominal pain, groin pain, abdominal wall fluid collection, and adhesions.Post-operative treatment included revision surgery,incision/drainage/debridement of the seroma cavity, placement of a wound vac, three additional placements of new mesh during repairs of incisional/inguinal/ventral hernias, panniculectomy, implant of pain pump, wound drainage, incision and unroofing of abscess, excision of lesion, and adhesion removal.
 
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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 Key7667214
MDR Text Key113339582
Report Number9617613-2018-00062
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K992556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/13/2007
Device Model NumberP151828
Device Catalogue NumberP151828
Device Lot Number05B25-9
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/13/2018
Initial Date FDA Received07/06/2018
Supplement Dates Manufacturer Received06/05/2019
06/05/2019
06/05/2019
Supplement Dates FDA Received10/06/2019
12/26/2019
02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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