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

Model Number PCO2015FX

Device Problems Degraded (1153); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)

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 ventral hernia.It was reported that after implant, the patient experienced broken down mesh, mesh failure, hernia recurrence, adhesions, bowel complications, pain, defective mesh, scarring, disfigurement, psychological and emotional injuries, suffering, loss of enjoyment of life, disability, and loss of mental and emotional health.Post-operative patient treatment included revision surgery.

Manufacturer Narrative

Additional information: b5, g3, added imf code and removed code e2107 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 ventral hernia.It was reported that after implant, the patient experienced broken down mesh, mesh failure, hernia recurrence, adhesions, bowel complications, pain, defective mesh, scarring, disfigurement, psychological and emotional injuries, suffering, loss of enjoyment of life, disability, and loss of mental and emotional health.Post-operative patient treatment included revision surgery and corrective surgery with mesh.

• Brand Name: PARIETEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 12345032
• MDR Text Key: 267353528
• Report Number: 9615742-2021-02058
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179752
• UDI-Public: 10884521179752
• Combination Product (y/n): N
• PMA/PMN Number: K110663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCO2015FX
• Device Catalogue Number: PCO2015FX
• Device Lot Number: P5B1198X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PCO9FX PARIETEX PCOX RND THR 9CM X1 (LOT#POB0541X).; PCO9FX PARIETEX PCOX RND THR 9CM X1 (LOT#POB0541X)
• Patient Outcome(s): Required Intervention; Disability