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

Model Number UNKNOWN PARIETEX

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Seroma (2069); Urinary Frequency (2275); Injury (2348); Hematuria (2558); Ascites (2596); Abdominal Distention (2601); Fibrosis (3167); 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a hernia repair with mesh.He had revision surgery 10 years and 3 months post-surgery.The patient experienced removal or revision surgery resulting from complications from mesh.

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 hernia.It was reported after implant, the patient experienced fluid collection, adhesions and infection.Post-operative patient treatment included revision/removal surgery, right side hydrocelectomy and drainage of right lower quadrant preperitoneal.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a right inguinal hernia.It was reported after implant, the patient experienced fluid collection, adhesions, infection, foreign body reaction, fibrosis, hydrocele, pain, bulging, purulent drainage, urinary frequency, inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, and displaced mesh.Post-operative patient treatment included revision/removal surgery, right side hydrocelectomy and drainage of right lower quadrant preperitoneal.

Manufacturer Narrative

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

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 laparoscopic therapeutic treatment of a right inguinal hernia.It was reported after implant, the patient experienced fluid collection, adhesions, infection, foreign body reaction, fibrosis, hydrocele, groin pain, bulging, purulent drainage, urinary frequency, and displaced mesh.Post-operative patient treatment included revision/removal surgery, right side hydrocelectomy and drainage of right lower quadrant preperitoneal.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a right inguinal hernia.It was reported after implant, the patient experienced seroma, hematuria, left flank pain, fluid collection, adhesions, infection, foreign body reaction, fibrosis, hydrocele, pain, bulging, purulent drainage, urinary frequency, inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, and displaced mesh.Post-operative patient treatment included multiple hospitalizations, surgical procedures, aspiration of abdominal fluid collection, diagnostic laparoscopy, cystoscopy, medication, ultrasound, revision surgery, excision of infected mesh, right side hydrocelectomy and drainage of right lower quadrant preperitoneal.Relevant tests/laboratory data: 25 aug 2017: per op note, ultrasound revealed fluid collection 6.5 x 4.1 x 4.2 cm.28 aug 2017: surgical pathology report reveals surgical mesh with foreign body type granulomata, fibrosis and granulation tissue.

Manufacturer Narrative

Additional info: (added hospitalization), (patient codes, imf 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.

• 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: 7340497
• MDR Text Key: 102432837
• Report Number: 9615742-2018-00505
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 90 KG