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

Model Number PCO2520X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Edema (1820); Erythema (1840); Foreign Body Reaction (1868); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scarring (2061); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Blood Loss (2597); Fibrosis (3167); 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, small bowel obstruction, dense visceral adhesions of the small bowel to the mesh infection and partial removal of the mesh. Treatment provided for these conditions include removal.

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 a ventral incisional hernia. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, small bowel obstruction, necrosis, dense visceral adhesions of the small bowel to the mesh, hematoma, open wound, bleeding, and infection. Treatment provided for these conditions include removal, exploratory laparotomy, repair of hernia, repair of enterotomies small bowel, evacuation of hematoma, wound washout and debridement, wound vac, and partial removal of the mesh.

• 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: 7970700
• MDR Text Key: 123875662
• Report Number: 9615742-2018-02287
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/02/2020

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

• Device Expiration Date: 07/31/2018
• Device Model Number: PCO2520X
• Device Catalogue Number: PCO2520X
• Device Lot Number: PNH0288X
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/16/2018 Patient Sequence Number: 1