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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
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.
 
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Brand Name
PARIETEX MESH
Type of Device
PARIETEX MESH
Manufacturer (Section D)
COVIDIEN
MDR Report Key4993041
MDR Text Key23536865
Report NumberMW5055272
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
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 Received08/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age77 YR
Patient Weight50
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