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

Model Number TECR1510

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

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Foreign Body Reaction (1868); Hyperplasia (1906); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Hernia (2240); Anxiety (2328); Injury (2348); Depression (2361); Impaired Healing (2378); No Code Available (3191); 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 hernia.It was reported that after a procedure where this device was implanted, the patient experienced an unspecified adverse outcome.After the original procedure additional surgeries were performed, including revision.

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 hernia.It was reported that after onlay implant, the patient experienced recurrence, infection, pain, chronic inflammation, scarification,mesh encapsulation, lack of adequate ingrowth, adhesions, cellulitis, infection positive for staphylococcus, foreign body reaction, hypertrophic scar, open wound, and hyperkeratotic epidermal hyperplasia.Post-operative patient treatment included revision surgery with new surgimend 20x25 mesh implanted, lysis of adhesions, suction irrigation of wound with antibiotic solution, and excision of skin, subcutaneous tissue, and muscle.

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 hernia.It was reported that after onlay implant, the patient experienced recurrence, adhesions, cellulitis, infection positive for staphylococcus, foreign body reaction, hypertrophic scar, open wound, and hyperkeratotic epidermal hyperplasia.Post-operative patient treatment included revision surgery with new surgimend 20x25 mesh implanted, lysis of adhesions, suction irrigation of wound with antibiotic solution, and excision of skin, subcutaneous tissue, and muscle.

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.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 recurrence, adhesions, and infection.Post-operative patient treatment included revision surgery with new surgimend 20x25 mesh implanted.

Manufacturer Narrative

Additional information: b5, b7, g1(manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6(patient codes), additional 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 ventral hernia.It was reported that after onlay implant, the patient experienced weakened abdominal wall, depression, anxiety, diabetes, recurrence, infection, pain, chronic inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, adhesions, cellulitis, infection positive for staphylococcus, foreign body reaction, hypertrophic scar, open wound, and hyperkeratotic epidermal hyperplasia.Post-operative patient treatment included revision surgery with new surgimend 20x25 mesh implanted, lysis of adhesions, suction irrigation of wound with antibiotic solution, medication, excision of skin, subcutaneous tissue and muscle, exploratory laparotomy, and mesh removal,.Relevant tests/laboratory data: (b)(6) 2013: per op note, cultures of wound consistent with staph (b)(6) 2014: pathology specimen reports foreign body granulomatous inflammation with hypertrophic scar & hyperkeratotic epidermal hyperplasia.

• Brand Name: PARIETEX MESH
• 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: 7589761
• MDR Text Key: 110699769
• Report Number: 9615742-2018-01289
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: TECR1510
• Device Catalogue Number: TECR1510
• Device Lot Number: SNA00037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2022
• Date Device Manufactured: 01/12/2013
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White