MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC

Model Number PCO2520OSX

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Emotional Changes (1831); Erythema (1840); Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Vomiting (2144); Dizziness (2194); Electrolyte Imbalance (2196); Hernia (2240); Distress (2329); Impaired Healing (2378); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced premature resorption of the collagen coating, defective mesh, adhesions, pain, inflammation, bowel problems, infection, mental pain, emotional distress, disability, impairment, loss of enjoyment of life.Post-operative patient treatment included mesh revision, takedown of adhesions.

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 a ventral hernia.It was reported that after implant, the patient experienced premature resorption of the collagen coating, defective mesh, adhesions, pain, suffering, inflammation, bowel problems, infection, mental pain, emotional distress, disability, impairment, recurrence, non-healing wound, exposed mesh, hole in mesh, evisceration, loss of enjoyment of life.Post-operative patient treatment included revision surgery, mesh revision, hernia repair with new mesh, takedown of adhesions, wound dehiscence, and exploratory laparotomy.

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.

Manufacturer Narrative

H6 (patient codes <(>&<)> ime e2402: mild colonic ileus, abnormal pancytopenia; white cell count; hematocrit, renal insufficiency).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 incisional hernia.It was reported that after implant, the patient experienced premature resorption of the collagen coating, defective mesh, adhesions, pain, suffering, inflammation, bowel problems, infection, mental pain, emotional distress, disability, impairment, recurrence, non-healing wound, exposed mesh, hole in mesh, evisceration, loss of enjoyment of life, mild colonic ileus, abnormal levels of sodium; chloride; pancytopenia; white cell count; hematocrit, abdomen distended; firm; erythematous, wound dehiscence, nausea, vomiting, dizziness, fatigue, hyponatremia, hypochloremia, hypokalemia, chronic renal insufficiency, rectus diastasis, evisceration, <(>&<)> dehiscence.Post-operative patient treatment included revision surgery, mesh revision, hernia repair with new mesh, takedown of adhesions, exploratory laparotomy, x-ray, debridement of wound dehiscence, hospitalization, iv fluids, lysis of adhesions, primary closure of fascia, mesh debrided, <(>&<)> iv antibiotics.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15533501
• MDR Text Key: 301085417
• Report Number: 9615742-2022-00899
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179820
• UDI-Public: 10884521179820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110816
• 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
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2013
• Device Model Number: PCO2520OSX
• Device Catalogue Number: PCO2520OSX
• Device Lot Number: PLH00172
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2023
• 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
• Treatment: UNKNOWN TACKER
• Patient Outcome(s): Disability; Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White