MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number PCO9X

Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506); 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); Cellulitis (1768); Fistula (1862); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Perforation (2001); Scar Tissue (2060); Seroma (2069); Hernia (2240); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturer reference number: (b)(4).Patient information not provided.Incident date was not provided.Udi not provided.Re-processing information not provided.

Event Description

According to the reporter: the patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient developed significant issues relating to the device including severe pain and discomfort.Approximately 3 years post op the patient was admitted to the hospital for removal of the mesh product.The patient had incredible complications requiring multiple surgical procedures during the several sequential hospital stays including affect upon her internal organs including her large and small intestines, bowel obstruction, re-routing of her rectum, and defecation through her umbilicus.

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.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 infection, fistula, open wound, severe pain and discomfort, dense adhesions, affect upon her internal organs including her large and small intestines, bowel obstruction, and defecation through her umbilicus.Post-operative patient treatment included revisions, removal of mesh, incision and drainage with debridement of infection, wound vac, hernia repair, bilateral component separation, re-routing of her rectum, small bowel resection, and resection of enterocutaneous fistula.

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 incarcerated ventral hernia.It was reported that after implant, the patient experienced infection, fistula, abscess cavity, necrotic tissue, open wound, severe pain and discomfort, dense adhesions, abdominal pain, abdominal cellulitis, affect upon her internal organs including her large and small intestines, bowel obstruction, and defecation through her umbilicus.Post-operative patient treatment included revisions, removal of mesh, incision and drainage with debridement of infection, wound vac, hernia repair, bilateral component separation, re-routing of her rectum, wound vac, small bowel resection, and resection of enterocutaneous fistula.

Manufacturer Narrative

Additional info: a4, b2, b5, b7, d8, e1 (street 1, city, region, postal code), g1, & h6 (patient codes, device codes, eval code method, eval code result, eval code conclusion, ime e2402: defecation through umbilicus).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 an incarcerated ventral hernia.It was reported that after implant, the patient experienced infection, fistula, abscess cavity, necrotic tissue, open wound, severe pain/discomfort, dense adhesions, abdominal pain, abdominal cellulitis, affect upon internal organs including large and small intestines, bowel obstruction, defecation through umbilicus, hernia recurrence, hematoma, inflammation, bleeding, seroma, perforation, mesh migration, scarification, mesh encapsulation, anxiety, distress, disability, brown mesh material, and lack of adequate ingrowth.Post-operative patient treatment included revisions, removal of mesh, incision and drainage with debridement of infection, wound vac, hernia repair, bilateral component separation, re-routing of her rectum, wound vac, small bowel resection, resection of enterocutaneous fistula, hernia repair with bard mesh, & medication.Relevant tests/laboratory data, including dates (b6), (b)(6) 2016: labs abnormal for wbc of 17.5 (b)(6) 2016: labs abnormal for wbc of 20.8 (b)(6) 2016: pathology report from (b)(6) 2016 surgery- brown mesh material with numerous blue sutures.Mucosa surrounding suture areas were red-brown and hemorrhagic.

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 an incarcerated ventral hernia.It was reported that after implant, the patient experienced infection, fistula, abscess cavity, necrotic tissue, open wound, severe pain/discomfort, dense adhesions, abdominal pain, abdominal cellulitis, affect upon internal organs including large and small intestines, bowel obstruction, defecation through umbilicus, hernia recurrence, hematoma, inflammation, bleeding, seroma, perforation, mesh migration, scarification, mesh encapsulation, anxiety, distress, disability, brown mesh material, phlegmon, bacterial infection, large fluid drainage, and lack of adequate ingrowth.Post-operative patient treatment included revisions, removal of mesh, incision and drainage with debridement of infection, wound vac/care, hernia repair, bilateral component separation, re-routing of rectum, wound vac, small bowel resection, resection of enterocutaneous fistula, hernia repair with new mesh, ct scan, abdominal binder, admission to hospital, and medication.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE 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 ; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 6819996
• MDR Text Key: 83622897
• Report Number: 9615742-2017-05206
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179875
• UDI-Public: 10884521179875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: PCO9X
• Device Catalogue Number: PCO9X
• Device Lot Number: PNB0263
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2013
• 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): Hospitalization; Required Intervention; Other; Disability
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: White