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

Model Number PCO3728FX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bacterial Infection (1735); Chest Pain (1776); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pleural Effusion (2010); Tachycardia (2095); Hernia (2240); Distress (2329); Injury (2348); Depression (2361); Impaired Healing (2378); Diaphoresis (2452); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559); 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 a diaphragmatic hernia.It was reported that after implant, the patient experienced physical pain, mental anguish, depression, and hernia recurrence.Post-operative treatment included anterior ventral hernia repair and removal of the mesh.After removal, the patient required additional implants of mesh and recurrent hernia repairs.

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 diaphragmatic hernia.It was reported that after implant, the patient experienced physical pain, mental anguish, depression, disability, psychological stress, loss of enjoyment of life, and hernia recurrence.Post-operative treatment included anterior ventral hernia repair, additional surgeries, hospitalization, hernia repair with new implants, repair the anterior chest wall and anterior abdominal wall defect with mesh, reconstruct the anterior inferior aspect of diaphragm with mesh, and removal of the mesh.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a diaphragmatic hernia.It was reported that after implant, the patient experienced physical pain, mental anguish, depression, disability, psychological stress, loss of enjoyment of life, pleural effusion, staphylococcus aureus, abscess, foreign body reaction, fluid collection, stranding and thickening in chest wall, fistula tract, inflammation, bloody secretion, chest pain, unable to take deep breaths, tachycardia, tachypneic, erythema, fluctuance, drainage, purulent discharge, infection, redness, partial disruption of wound, open wound, bulge, draining sinus, induration, ileus, dependence on opiates, agitation, diaphoretic, withdrawals, and hernia recurrence.Post-operative treatment included anterior ventral hernia repair, additional surgeries, hospitalization, hernia repair with new implants, repair the anterior chest wall and anterior abdominal wall defect with mesh, reconstruct the anterior inferior aspect of diaphragm with mesh, admission to ed, required oxygen, wound irrigated and dressed, iv fluids, antibiotics, iv dilaudid, wound vac, ct guided pla cement of catheter, picc line inserted, removal of stitches, medications, prescribed keflex, partial removal of mesh, icu, and removal of the mesh.

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.

• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 9320063
• MDR Text Key: 166303434
• Report Number: 9615742-2019-03725
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179660
• UDI-Public: 10884521179660
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110663
• 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: 04/06/2022

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: 12/31/2019
• Device Model Number: PCO3728FX
• Device Catalogue Number: PCO3728FX
• Device Lot Number: PPA0498X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 10/13/2021; 03/16/2022
• Supplement Dates FDA Received: 11/03/2021; 04/06/2022
• Date Device Manufactured: 01/29/2015
• 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; Disability; Hospitalization
• Patient Sex: Male
• Patient Weight: 133 KG