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

Model Number P101520

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Erythema (1840); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Muscle Weakness (1967); Nausea (1970); Pain (1994); Perforation (2001); Seroma (2069); Vomiting (2144); Hernia (2240); Discomfort (2330); Injury (2348); Depression (2361); Impaired Healing (2378); Obstruction/Occlusion (2422); Respiratory Failure (2484); Sleep Dysfunction (2517); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 an infected ventral hernia.It was reported that after underlay implant, the patient experienced severe pain, hernia recurrence, adhesions, infection, unincorporated mesh and small bowel obstruction with strangulated bowel.Post-operative patient treatment included mesh removal.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an infected incisional hernia.It was reported that after underlay implant, the patient experienced severe pain, hernia recurrence, adhesions, infection, unincorporated mesh and small bowel obstruction with strangulated bowel.Post-operative patient treatment included mesh removal.Relevant tests/lab data: on (b)(6) 2016: op note stated white count of 20 and a ct scan that noted a piece of strangulated small bowel inside of his very large ventral hernia.

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.

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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an infected incisional hernia.It was reported that after underlay implant, the patient experienced severe pain, hernia recurrence, adhesions, infection, fistulas, mesh migration, digestive problems, can't fall asleep, depression, bloating, soreness, unincorporated mesh and small bowel obstruction with strangulated bowel.Post-operative patient treatment included revision surgery, mesh removal, hernia repair with new mesh, and ct scan.Relevant tests/lab data: (b)(6) 2016: op note stated white count of 20 and a ct scan that noted a piece of strangulated small bowel inside of his very large ventral hernia.

Manufacturer Narrative

H6 (patient codes).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 an infected incisional hernia.It was reported that after underlay implant, the patient experienced severe pain, hernia recurrence, adhesions, infection, fistulas, mesh migration, digestive problems, can't fall asleep, depression, bloating, soreness, unincorporated mesh, small bowel obstruction with strangulated bowel, small free fluid, inflammation in hernia sac, chronic postsurgical collection, contained perforation, seroma, mesenteric edema, attenuation, abnormal lactate levels, bloody fluid drainage, abdominal wall abscess, induration, crampy abdominal pain, dry heaves, nausea, vomiting, open abdominal wound, serosanguinous drainage, bulge, tender, cellulitis, erythema, itching.Post-operative patient treatment included revision surgery, mesh removal, multiple hernia repair with new mesh, ct scan, picc line, iv antibiotics, pain medication, exploratory laparotomy, lysis of adhesions, icu, extubated, supplemental oxygen, wound care, bilateral jp drains, hospitalization, ng tube, electrolyte repletion.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an infected incisional hernia.It was reported that after underlay implant, the patient experienced severe pain, hernia recurrence, adhesions, infection, fistulas, mesh migration, digestive problems, can't fall asleep, depression, bloating, soreness, unincorporated mesh, small bowel obstruction with strangulated bowel, small free fluid inflammation in hernia sac, chronic postsurgical collection, contained perforation, seroma, mesenteric edema, attenuation, abnormal lactate levels, bloody fluid drainage, abdominal wall abscess, induration, abdominal pain, dry heaves, nausea, vomiting, open abdominal wound, serosanguinous drainage, bulge, tender, cellulitis, erythema, itching.Post-operative patient treatment included revision surgery, mesh removal, multiple hernia repair with new mesh, ct scan, picc line, iv antibiotics, pain medication, exploratory laparotomy, lysis of adhesions, icu, extubated, supplemental oxygen, wound care, bilateral jp drains, hospitalization, ng tube, electrolyte repletion.

Manufacturer Narrative

Additional info: a5b, b2, b5, b6, b7, d4 (model #, catalog #, expiration date, unique identifier (udi) #), d6b removed date, d8, g3 (pma / 510(k) #), h6 (patient codes, ime e2402: abnormal lactate levels, induration, dry heaves).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.

• 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
• Manufacturer (Section G): TISSUE SCIENCE LABORATORIES; victoria house, victoria road; aldershot, hampshire GU11 1EJ; GB GU11 1EJ
• Manufacturer Contact: justin ellis ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 9538880
• MDR Text Key: 182401599
• Report Number: 9617613-2020-00001
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10884523000122
• UDI-Public: 10884523000122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/22/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2013
• Device Model Number: P101520
• Device Catalogue Number: P101520
• Device Lot Number: 09B2909
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 01/08/2020; 01/11/2023; 01/25/2023; 02/22/2023
• Supplement Dates FDA Received: 01/15/2020; 01/11/2023; 02/22/2023; 02/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White