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

Model Number PCO1510OSX

Device Problems Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Anemia (1706); Cyst(s) (1800); Dyspnea (1816); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Pain (1994); Hernia (2240); Injury (2348); Blood Loss (2597); No Code Available (3191); Nodule (4551); 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 repair of recurrent incisional hernia with mesh.She had revision surgery 1 year and 4 months post-surgery.The patient experienced chronic pain, mesh contraction/failure 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 therapeutic treatment of a recurrent incisional hernia with mesh.It was reported that after the implant, the patient experienced chronic pain, mesh contraction/failure, recurrence, mild diverticulosis, cyst, esophagitis, shortness of breath, bleeding, anemia, small tear in spleen, and adhesions.Post-operative patient treatment included revision surgery, repair of hernia, lysis of adhesions, repair of small tear in spleen, and excision of 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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment of a recurrent incisional hernia with mesh.It was reported that after the implant, the patient experienced chronic pain, mesh contraction/failure, recurrence, and adhesions.Post-operative patient treatment included revision surgery and excision of mesh.

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 therapeutic treatment of a recurrent incisional hernia with mesh.It was reported that after the implant, the patient experienced defective device, mental pain, disability, impairment, loss of enjoyment of life, chronic pain, mesh contraction/failure, recurrence, mild diverticulosis, cyst, esophagitis, shortness of breath, bleeding, anemia, small tear in spleen, and adhesions.Post-operative patient treatment included revision surgery, repair of hernia, lysis of adhesions, repair of small tear in spleen, hernia repair with mesh, and excision of mesh.

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 therapeutic treatment of a recurrent incisional hernia with mesh.It was reported that after the implant, the patient experienced defective device, mental pain, disability, impairment, loss of enjoyment of life, chronic pain, mesh contraction/failure, recurrence, mild diverticulosis, cyst, esophagitis, shortness of breath, bleeding, anemia, small tear in spleen, lump in stomach, and adhesions.Post-operative patient treatment included revision surgery, repair of hernia, lysis of adhesions, repair of small tear in spleen, hernia repair with mesh, ct-scan, primary care, and excision of mesh.Relevant tests/laboratory data 02 jun 2016- ct scan demonstrated 2 new hernias of the upper abdominal wall containing fat, as well as a large hiatal hernia, mild diverticulosis, right diaphragmatic hernia, and left adnexal cyst.Egd noted hiatal hernia with associated esophagitis.

• 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 ; 5920 longbow dr; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 7034968
• MDR Text Key: 92116159
• Report Number: 9615742-2017-05759
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179691
• UDI-Public: 10884521179691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110816
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: PCO1510OSX
• Device Catalogue Number: PCO1510OSX
• Device Lot Number: POB0573X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2023
• Date Device Manufactured: 03/06/2014
• 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; Other; Disability
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White