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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 77 YR
• Patient Weight: 50