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

Model Number PCO2015X

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 Abscess (1690); Adhesion(s) (1695); Inflammation (1932); Scar Tissue (2060); Seroma (2069); Hernia (2240); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 left inguinal hernia recurrence, free-floating mesh, large seroma, abscess, scarred down tissue, spermatic cord isolated and encircled, dense fibrous tissue, giant cells, inflammation, adhesions, direct defect around spermatic cord, and left lower quadrant hernia recurrence.Post-operative patient treatment included removal of free-floating mesh, drainage of scrotum, suture approximation of the tissue around spermatic cord, placement of new meshes, lysis of adhesions and adhesions taken down, new lifecell strattice mesh implanted, plugs implanted, and ventrio st implanted.The device was used with a secure strap.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8987711
• MDR Text Key: 157457868
• Report Number: 9615742-2019-03036
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179769
• UDI-Public: 10884521179769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: PCO2015X
• Device Catalogue Number: PCO2015X
• Device Lot Number: PQJ0958X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Date Device Manufactured: 11/10/2016
• 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: SECURE STRAP
• Patient Outcome(s): Required Intervention