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

Model Number PCO2015OSX

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)

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 implant, the patient experienced chronic pain, non-healing superficial wound, and infection.Post-operative patient treatment included revision and removal surgery.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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 ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, chronic draining abdominal wound, non-healing superficial wound, staphylococcus aureus, purulent material, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, and infection.Post-operative patient treatment included revision surgery, wound vac, excision of chronic draining wound, antibiotics, component separation, and removal surgery.

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.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 incisional hernia.It was reported that after implant, the patient experienced recurrence, chronic pain, chronic draining abdominal wound, non-healing superficial wound, staphylococcus aureus, purulent material, and infection.Post-operative patient treatment included revision surgery, wound vac, excision of chronic draining wound, antibiotics, component separation, and removal surgery.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, chronic pain, chronic draining abdominal wound, non-healing superficial wound, and infection.Post-operative patient treatment included revision surgery, wound vac, excision of chronic draining wound, and removal surgery.

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.(b)(4).If information is provided in the future, a supplemental report will be issued.

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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced recurrence, chronic draining abdominal wound, non-healing superficial wound, staphylococcus aureus, purulent material, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, hypertrophic granulation tissue, foreign body reaction, and infection.Post-operative patient treatment included revision surgery, wound vac, excision of chronic draining wound, antibiotics, component separation, suture excision, ct-scan, and mesh removal surgery.Relevant tests/laboratory data: (b)(6) 2015: abnormal lab of bun 24.Wound culture with staphylococcus aureus.(b)(6) 2015: ct abdomen/pelvis showed prominent ductal hernia containing large and small bowel.Thickening of the skin and anterior abdominal wall on the superior margin of the hernia.Apr 2016: abdominal wound cultured at clinic visit and grew staphylococcus aureus.

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 incisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, chronic draining abdominal wound, non-healing superficial wound, staphylococcus aureus, purulent material, mental pain, pain, disability, impairment, loss of enjoyment of life, defective mesh, hypertrophic granulation tissue, foreign body reaction, and infection.Post-operative patient treatment included revision surgery, wound vac, excision of chronic draining wound, antibiotics, component separation, suture excision, ct-scan, and mesh removal surgery.

Manufacturer Narrative

Additional information: a5a (ethnicity) 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: justin ellis ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8174762
• MDR Text Key: 130676657
• Report Number: 9615742-2018-02815
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179806
• UDI-Public: 10884521179806
• 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,Followup,Followup
• Report Date: 10/31/2023

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: 10/10/2014
• Device Model Number: PCO2015OSX
• Device Catalogue Number: PCO2015OSX
• Device Lot Number: PMJ00636
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/05/2018; 06/05/2019; 06/05/2019; 01/26/2022; 08/30/2023; 10/11/2023; Not provided
• Supplement Dates FDA Received: 12/29/2018; 01/15/2020; 02/18/2020; 02/10/2022; 09/04/2023; 10/24/2023; 10/31/2023
• Date Device Manufactured: 11/06/2012
• 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: UNKABSTACK (LOT#: UNKNOWN).
• Patient Outcome(s): Required Intervention; Disability
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White