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

Model Number PCO2520

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

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Perforation (2001); Staphylococcus Aureus (2058); Discharge (2225); Injury (2348); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative diagnosis was recurrent ventral hernia and postoperative diagnosis was recurrent ventral hernia x2.The procedure performed was laparoscopic ventral hernia repair with mesh, lysis of adhesions.(b)(6) 2016 - patient underwent a procedure for incision and drainage of intraabdominal and subcutaneous abscess with removal of mesh and placement of drain.Preoperative and postoperative diagnosis was intraabdominal and subcutaneous abscess.(b)(6) 2016 - patient underwent a procedure for exploratory laparotomy, small bowel resection times two and lysis of adhesions.Preoperative and postoperative diagnosis was intracutaneous fistula.The patient has had a additional surgery; adhesions; infection; mesh removal and revision.

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.Product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced abscess, fistula, adhesions, infection, staphylococcus aureus and positive for multiple bacterial strains, bulge, necrotic tissue, and drainage of fecal content.Post-operative patient treatment included revision surgery, incision and drainage of intraabdominal and subcutaneous abscess with removal of mesh and placement of drain, exploratory laparotomy, small bowel resection, enterotomies, multiple blood transfusions, and lysis of adhesions.

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.Product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced abscess, fistula, adhesions, infection, and drainage of fecal content.Post-operative patient treatment included revision surgery, incision and drainage of intraabdominal and subcutaneous abscess with removal of mesh and placement of drain, exploratory laparotomy, small bowel resection, and lysis of adhesions.

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.Product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced perforation, abscess, fistula, adhesions, infection, staphylococcus aureus and positive for multiple bacterial strains, bulge, necrotic tissue, and drainage of fecal content.Post-operative patient treatment included revision surgery, incision and drainage of intraabdominal and subcutaneous abscess with removal of mesh and placement of drain, exploratory laparotomy, small bowel resection, enterotomies, multiple blood transfusions, mesh removal, medication, ct-scan, and lysis of adhesions.Relevant tests/laboratory data: 02/27/2016: microbiology report- culture abnormal with moderate e.Coli.02/28/2016: op note- ct scan demonstrated an abscess extending from intraperitoneally through the subcutaneous tissue and demonstrated communication with small bowel.02/28/2016: microbiology report- abnormal wound culture: scant staphylococcus aureus, moderate e.Coli, scant klebsiella oxytoca, and moderate streptococcus consetllatus.04/26/2016: microbiology report- abnormal wound culture: moderate e.Coli, moderate proteus vulgaris group, moderate strep constellatus.

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.Product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced perforation, abscess, fistula, adhesions, infection, staphylococcus aureus and positive for multiple bacterial strains, bulge, necrotic tissue, and drainage of fecal content.Post-operative patient treatment included revision surgery, incision and drainage of intraabdominal and subcutaneous abscess with removal of mesh and placement of drain, bowel removal, exploratory laparotomy, small bowel resection, enterotomies, multiple blood transfusions, mesh removal, medication, ct-scan, and lysis of adhesions.

Event Description

The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced perforation, abscess, fistula, adhesions, infection, staphylococcus aureus and positive for multiple bacterial strains, bulge, necrotic tissue, and drainage of fecal content.Post-operative patient treatment included revision surgery, incision and drainage of intraabdominal and subcutaneous abscess with removal of mesh and placement of drain, bowel removal, exploratory laparotomy, small bowel resection, enterotomies, multiple blood transfusions, mesh removal, medication, ct-scan, lysis of adhesions, & icu.

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.

• Brand Name: MESH SOFRADIM - PARIETEX¿ 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 ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 7010328
• MDR Text Key: 91358448
• Report Number: 9615742-2017-05667
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• 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: PCO2520
• Device Catalogue Number: PCO2520
• Device Lot Number: PKA00581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2024
• Date Device Manufactured: 02/06/2010
• 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: SEE SECTION H10
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White