MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Catalog Number PMH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Adhesion(s) (1695); Pain (1994); Perforation of Esophagus (2399); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is in reference to: mw5075609.

Event Description

It was reported that the patient underwent a hernia repair procedure in 2015 and mesh was implanted.The patient experienced severe pain, recurrence of adhesions, obstruction, perforation, lower back pain and some complications due to prior existing copd.During repair, the surgeon stated the mesh strangulated the esophagus, and scrapped off as much of the mesh as possible before declaring it unsafe to continue any longer and said it was inoperable.The surgeon believes that the healthcare professional who did the initial procedure had dug their fingernails into the skin of the patient which had led to an infection of the wound post-surgery.No additional information has been provided.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7508604
• MDR Text Key: 108093021
• Report Number: 2210968-2018-72771
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031049017
• UDI-Public: 10705031049017
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 04/16/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: PMH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/11/2018
• 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
• Patient Outcome(s): Required Intervention