MAUDE Adverse Event Report: COVIDIEN/SOFRADIM PRODUCTION PARIETEX VENTRAL PATCH ; MESH, SURGICAL, POLYMERIC

Model Number PCO6VP

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problems Flatus (1865); Gastritis (1874); Pain (1994); Discomfort (2330); Weight Changes (2607); No Code Available (3191)

Event Date 03/28/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 i had surgery to repair an umbilical hernia.A plastic mesh was implanted, it was a covidien parietex ventral patch (model number pco6vp).After the operation it never felt right, and eventually i had to go back to have the mesh removed.This was done on (b)(6) 2014 after a year of pain and discomfort.When the mesh was removed, it was found to have adhered to my small intestine and i had to have several inches of my intestine removed along with the mesh.This of course caused a lot of pain, and since that time my stomach has never felt the same.I cannot eat like i used to, i have gas and bloating and acid reflux, all of which i never had before.I still have pain in the area of the operation even after having a biological mesh placed over the area and the hernia has recurred.I want to report this because i want people to know about the dangers it may pose.I hope the fda can do something about this problem.

• Brand Name: PARIETEX VENTRAL PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN/SOFRADIM PRODUCTION
• MDR Report Key: 6680563
• MDR Text Key: 78987263
• Report Number: MW5070736
• 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: Patient
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2015
• Device Model Number: PCO6VP
• Device Lot Number: PML0023
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 82