MAUDE Adverse Event Report: WL. GORE ASSOCIATES GORETEX DUALPLUS 18CM X 2

Model Number 1DLMCP06

Device Problem Use of Device Problem (1670)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Perforation (2001); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

The patient had severe pain, recurrence of adhesions, obstruction, and perforation.His symptoms included cardiac at first, lower back pain, and some complications due to prior existing copd.Dr.(b)(6) at (b)(6) hospital during the repair stated the mesh had strangulated the esophagus, and scraped off as much of the mesh as possible before declaring it unsafe to continue any longer and said it was inoperable.Dr.(b)(6) was the physician who did the original placement surgery of the mesh at (b)(6) hospitals.On (b)(6) 2015, the patient had the first mesh that was placed, and the reporter believes that a healthcare professional at the hospital had dug their finger nails into the skin of the patient which had led to an infection of the wound post-surgery.

• Brand Name: GORETEX DUALPLUS 18CM X 2
• Type of Device: GORETEX DUALPLUS 18CM X 2
• Manufacturer (Section D): WL. GORE ASSOCIATES
• MDR Report Key: 7305691
• MDR Text Key: 101494085
• Report Number: MW5075609
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1DLMCP06
• Device Catalogue Number: 1DLMCP06
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 75