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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC

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COVIDIEN PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Perforation (2001)
Event Date 06/10/2021
Event Type  Injury  
Event Description
Need surgery to remove mesh; i had a nisson fundoplication for a hiatal hernia in 2009 and parietex composite mesh was used. The mesh has perforated into my stomach, causing pain, difficulty eating. I am scheduled to have surgery to remove the mesh, resect my stomach and repair the hiatal hernia in 2 weeks. Fda safety report id # (b)(4).
 
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Brand NamePARIETEX COMPOSITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key12569079
MDR Text Key274772716
Report NumberMW5104350
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/01/2021 Patient Sequence Number: 1
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