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

Model Number TECT1510AL

Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Fistula (1862); Granuloma (1876); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Swelling (2091); Discharge (2225); Hernia (2240); Injury (2348); Bowel Perforation (2668); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); 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 left inguinal hernia.It was reported that after implant, the patient experienced infection, left groin pain, groin swelling, seepage from wound, remnants of mesh, chronic inflammatory fibrous tissue, hard piece of granulation tissue contained small piece of mesh, left groin abscess, mesh torn, fistula, adhesions, left groin extremely scarred, and loop of colon scarred in and inflamed.Post-operative patient treatment included removal of mesh, incision and drainage of wound, wound packed and left open, excision of chronic inflammatory fibrous tissue, and wound vac placed.

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 left inguinal hernia.It was reported that after implant, the patient experienced recurrence, infection, left groin pain, groin swelling, seepage from wound, remnants of mesh, chronic inflammatory fibrous tissue, hard piece of granulation tissue contained small piece of mesh, left groin abscess, pus, mesh torn, mesh migration, fistula, adhesions, left groin extremely scarred, and loop of colon scarred in and inflamed.Post-operative patient treatment included removal of mesh, incision and drainage of wound, wound packed and left open, excision of chronic inflammatory fibrous tissue, lysis of adhesions, reduction of hernia, orchiopexy, mobilization of splenic flexure, sigmoidectomy, primary anastomosis, and wound vac placed.

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 left inguinal hernia.It was reported that after implant, the patient experienced recurrence, infection, mrsa, left groin pain, groin s welling, seepage from wound, chronic inflammatory fibrous tissue, hard piece of granulation tissue contained small piece of mesh, left groin abscess, pus, mesh torn, mesh migration, fistula, adhesions, left groin extremely scarred, and loop of colon scarred in and inflamed, colon perforation, hemorrhage at the perforation site, subserosal and mucosal vascular congestion.Post-operative patient treatment included removal of mesh, incision and drainage of wound, wound packed and left open, daily dressing changes, excision of chronic inflammatory fibrous tissue, lysis of adhesions, reduction of hernia, orchiopexy, mobilization of splenic flexure, sigmoidectomy, primary anastomosis, and wound vac placed.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after implant, the patient experienced granuloma, meshoma, mesh failure, recurrence, infection, mrsa, left groin pain, groin swelling, seepage from wound, chronic inflammatory fibrous tissue, hard piece of granulation tissue contained small piece of mesh, left groin abscess, pus, mesh torn, mesh migration, fistula, adhesions, left groin extremely scarred, and loop of colon scarred in and inflamed, colon perforation, hemorrhage at the perforation site, subserosal and mucosal vascular congestion.Post-operative patient treatment included curettage of fistula tract with wound debridement, partial removal of mesh, revision of mesh, removal of mesh, incision and drainage of wound, wound packed and left open, daily dressing changes, excision of chronic inflammatory fibrous tissue, lysis of adhesions, reduction of hernia, orchiopexy, ct scan, mobilization of splenic flexure, sigmoidectomy, primary anastomosis, prolonged use of antibiotics, bowel resection, and wound vac placed.

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.

Manufacturer Narrative

Additional info: a4, b5, b7, d8, e1, g1, h6 (all codes, e2402: subserosal and mucosal vascular congestion, meshoma) 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 left inguinal hernia.It was reported that after implant, the patient experienced granuloma, meshoma, mesh failure, recurrence, infection, mrsa, left groin pain, groin swelling, seepage from wound, chronic inflammatory fibrous tissue, hard piece of granulation tissue contained small piece of mesh, left groin abscess, pus, mesh torn, mesh migration, fistula, adhesions, left groin extremely scarred, and loop of colon scarred in and inflamed, colon perforation, hemorrhage at the perforation site, subserosal and mucosal vascular congestion.Post-operative patient treatment included curettage of fistula tract with wound debridement, partial removal of mesh, revision of mesh, removal of mesh, incision and drainage of wound, wound packed and left open, daily dressing changes, excision of chronic inflammatory fibrous tissue, lysis of adhesions, reduction of hernia, orchiopexy, mobilization of splenic flexure, sigmoidectomy, primary anastomosis, prolonged use of antibiotics, bowel resection, and wound vac placed.

• 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 ; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 8456601
• MDR Text Key: 140015292
• Report Number: 9615742-2019-00726
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: TECT1510AL
• Device Catalogue Number: TECT1510AL
• Device Lot Number: SHK00117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2022
• 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
• Treatment: UNKNOWN PROTACK (LOT# UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG