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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX MESH

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COVIDIEN PARIETEX MESH Back to Search Results
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.

 
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Brand NamePARIETEX MESH
Type of DevicePARIETEX MESH
Manufacturer (Section D)
COVIDIEN
MDR Report Key4993041
Report NumberMW5055272
Device Sequence Number1
Product CodeFTL
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 Received08/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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
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