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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WL. GORE ASSOCIATES GORETEX DUALPLUS 18CM X 2

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WL. GORE ASSOCIATES GORETEX DUALPLUS 18CM X 2 Back to Search Results
Model Number 1DLMCP06
Device Problem Use of Device Problem (1670)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Perforation (2001); Obstruction/Occlusion (2422)
Event Type  Injury  
Event Description
The patient had severe pain, recurrence of adhesions, obstruction, and perforation. His symptoms included cardiac at first, lower back pain, and some complications due to prior existing copd. Dr. (b)(6) at (b)(6) hospital during the repair stated the mesh had strangulated the esophagus, and scraped off as much of the mesh as possible before declaring it unsafe to continue any longer and said it was inoperable. Dr. (b)(6) was the physician who did the original placement surgery of the mesh at (b)(6) hospitals. On (b)(6) 2015, the patient had the first mesh that was placed, and the reporter believes that a healthcare professional at the hospital had dug their finger nails into the skin of the patient which had led to an infection of the wound post-surgery.
 
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Brand NameGORETEX DUALPLUS 18CM X 2
Type of DeviceGORETEX DUALPLUS 18CM X 2
Manufacturer (Section D)
WL. GORE ASSOCIATES
MDR Report Key7305691
MDR Text Key101494085
Report NumberMW5075609
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1DLMCP06
Device Catalogue Number1DLMCP06
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
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

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