MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES PERMACOL; MESH, SURGICAL

Model Number	P151520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Dehydration (1807); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Renal Failure (2041); Sepsis (2067); Vomiting (2144); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Respiratory Failure (2484); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, wound dehiscence with evisceration, grossly distended abdomen, drainage from skin incision, bowel nearly protruding through skin incision, light fibrinous inflammatory adhesions, extensive gaseous distended ileus, sepsis, respiratory failure, purulent material in subcutaneous space, fibrinous adhesions, abdominal bloating, nausea, vomiting, non-healing wound on abdomen, bowel obstruction, dehydration, acute renal failure, leukocytosis, and multiple hospitalizations.Post-operative patient treatment included revision surgeries, lysis of adhesions, exploratory laparotomy, and mesh removal.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional info: a4, b2 (updated to include life threatening and hospitalization), b5, b7, h6 (updated all codes, added imf codes, patient codes and ime e2402: "ileus, dehydration, leukocytosis").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.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent ventral incisional hernia.It was reported that after implant, the patient experienced abscess, fistula, pain, infection, abdominal pain, recurrence, wound dehiscence with evisceration, grossly distended abdomen, drainage from skin incision, bowel nearly protruding through skin incision, light fibrinous inflammatory adhesions, extensive gaseous distended ileus, sepsis, respiratory failure, purulent material in subcutaneous space, fibrinous adhesions, abdominal bloating, nausea, vomiting, non-healing wound on abdomen, bowel obstruction, dehydration, acute renal failure, and leukocytosis.Post-operative patient treatment included wound vac, medication, revision surgeries, lysis of adhesions, exploratory laparotomy, mesh removal, hospital admission, component separation, bilateral myocutaneous flap, and hernia repair with new mesh.

• Brand Name: PERMACOL
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; UK GU11 1EJ
• Manufacturer Contact: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 9472741
• Report Number: 9615742-2019-03866
• Device Sequence Number: 2751719
• Product Code: FTM
• UDI-Device Identifier: 10884523000184
• UDI-Public: 10884523000184
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: P151520
• Device Catalogue Number: P151520
• Device Lot Number: 10B1201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 09/15/2021; 10/04/2023; 10/18/2023
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 10/01/2021; 10/09/2023; 10/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 115 KG