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

Model Number TECR1515

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Diarrhea (1811); Purulent Discharge (1812); Erythema (1840); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Burning Sensation (2146); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Fungal Infection (2419); Ascites (2596); No Code Available (3191); Thrombosis/Thrombus (4440); 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 a hernia was reported that after a procedure where this device was implanted, the patient experienced multiple surgical revisions and infection.After treatment, the patient experienced multiple surgical revisions, infection.

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 an incisional hernia.It was reported that after implant, the patient experienced infection, abscess, necrosis and open wound.Post-operative patient treatment included removal of infected mesh, incision and drainage of abscess, excision of necrotic skin and fat, closure of wound and wound vac placement.

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 large incisional hernia.It was reported that after implant, the patient experienced infection, recurrence, adhesions, pain, abscess, necrosis, open wound, purulent discharge, positive for staph aureus and pseudomonas, and scar tissue.Post-operative patient treatment included removal of infected mesh, incision and drainage of abscess, excision of necrotic skin and fat, closure of wound and wound vac placement.

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.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 large incisional hernia.It was reported that after implant, the patient experienced infection, abscess, necrosis, open wound, purulent discharge, positive for staph aureus and pseudomonas, and scar tissue.Post-operative patient treatment included removal of infected mesh, incision and drainage of abscess, excision of necrotic skin and fat, closure of wound and wound vac placement.

Manufacturer Narrative

Additional info: a4, b5, b7, g1, g3, h6 (added 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 a large incisional hernia.It was reported that after implant, the patient experienced suffering, burning and swelling from belly button with smelly discharge, inflammation, infection, recurrence, adhesions, pain, abscess, necrosis, open wound, purulent discharge, positive for staph aureus and pseudomonas, and scar tissue.Post-operative patient treatment included extended wound care, incision and drainage of abdominal wall, medication, partial removal of mesh, removal of infected mesh, incision and drainage of abscess, excision of necrotic skin and fat, closure of wound and wound vac placement.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a large incisional hernia.It was reported that after implant, the patient experienced suffering, burning and swelling from belly button with smelly discharge, inflammation, infection, recurrence, adhesions, pain, abscess, necrosis, open wound, purulent discharge, positive for staph aureus and pseudomonas, scar tissue, positive for klebsiella and presumptive candida, thrombus in right leg, inflammatory changes, fluid collection, positive for mrsa, perforated bowel with entrapped mesh, abdominal wound, nausea, calf tenderness, bleeding from wound site, irritation/redness around wound, eschar and induration at wound site, draining sinus, abdominal pain, & diarrhea.Post-operative patient treatment included extended wound care, incision and drainage of abdominal wall, medication, partial removal of mesh, removal of infected mesh, incision and drainage of abscess, excision of necrotic skin and fat, closure of wound, wound vac placement, ultrasound, ct scan, small bowel resection, skin sloughing, wound debridement, necrotic debridement, & aspiration of infected fluid.

Manufacturer Narrative

Additional info: a4, b5, b6, b7, h6 (patient codes, device codes) & ime e2402: induration, draining sinus.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: 7658750
• MDR Text Key: 113027236
• Report Number: 9615742-2018-01442
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TECR1515
• Device Catalogue Number: TECR1515
• Device Lot Number: SGD00198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2022
• 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; Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: White