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

Model Number PCO2015OSX

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Dehydration (1807); Purulent Discharge (1812); Failure of Implant (1924); Unspecified Infection (1930); Necrosis (1971); Pneumonia (2011); Renal Failure (2041); Staphylococcus Aureus (2058); Sepsis (2067); Shock (2072); Hernia (2240); Injury (2348); Impaired Healing (2378); Ventilator Dependent (2395); Obstruction/Occlusion (2422); No Code Available (3191)

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 hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, bowel obstruction, adhesions, infected mesh, and component separation of the mesh.Treatment provided for these conditions include removal surgery.

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 open central hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, purulent discharge, (b)(6), sepsis, shock, delirium, pneumonia, ventilator support, dehydration, acute renal failure, mesh migration, necrosis, non-healing wound, bowel obstruction, adhesions and infected mesh.Post-operative patient treatment included removal of infected mesh, lysis of adhesions, debridement of skin and subcutaneous tissue, partial omentectomy, complex reconstruction of abdominal wall, bilateral anterior component separation with retrorectus placement of biologic mesh, primary closure of fascia in the midline, placement of wound vac dressing, removal of necrotic fat to improve wound healing, washout of wound, esophagogastroduodenoscopy and tiger tube placement in small bowel.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after underlay implant, the patient experienced recurrent hernia due to failure of the mesh, purulent discharge, (b)(6), sepsis, shock, delirium, pneumonia, ventilator support, dehydration, severe protein-calorie malnutrition, acute renal failure, mesh migration, necrosis, non-healing wound, bowel obstruction, adhesions and infected mesh.Post-operative patient treatment included removal of infected mesh, lysis of adhesions, debridement of skin and subcutaneous tissue, partial omentectomy, complex reconstruction of abdominal wall, bilateral anterior component separation with retrorectus placement of biologic mesh, primary closure of fascia in the midline, placement of wound vac dressing, removal of necrotic fat to improve wound healing, washout of wound, esophagogastroduodenoscopy and tiger tube placement in small bowel.

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.

• 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
• MDR Report Key: 7972490
• MDR Text Key: 123933621
• Report Number: 9615742-2018-02314
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179806
• UDI-Public: 10884521179806
• Combination Product (y/n): N
• PMA/PMN Number: K110816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: PCO2015OSX
• Device Catalogue Number: PCO2015OSX
• Device Lot Number: PMJ00636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention