MAUDE Adverse Event Report: COVIDIEN PARIETEX MESH

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Gastritis (1874); Unspecified Infection (1930); Ulcer (2274)

Event Date 01/09/2013

Event Type  Injury  

Event Description

In (b)(6) 2013, using parietex mesh made by covidien, i had transesophageal repair of a hiatal hernia. In (b)(6) 2013, it was discovered that the mesh had migrated to my stomach causing an ulcer and infection. In (b)(6) 2013, i had removal of most of the mesh, along with part of my stomach. Some of the mesh had to be left on my liver and large blood vessels. I have since been diagnosed with gastroparesis and am on a very strict diet. I have continuous severe pain over the operative site.

• Brand Name: PARIETEX MESH
• Type of Device: PARIETEX MESH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 4993041
• MDR Text Key: 23536865
• Report Number: MW5055272
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 08/03/2015 Patient Sequence Number: 1