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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HERNIA MESH MESH, SURGICAL, POLYMERIC

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HERNIA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)
Patient Problem Malaise (2359)
Event Date 10/04/2019
Event Type  No Answer Provided  
Event Description

I'm writing to you about the 2016 recall concerning the hernia mesh. I have situation where i have two "doses" of mesh in me, resulting from an upper hernia mesh in 2008 and a lower hernia mesh in 2012 surgery. My body and my health hasn't been the same since. I'm writing to you for a full report on the situation concerning this hernia mesh, and how i can make situation better, because i'm in bad shape. Thank you for your time and concern, and i will appreciate it even more for your prompt reply to this problem. Thanks again.

 
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Brand NameHERNIA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
MDR Report Key9310591
MDR Text Key166222499
Report NumberMW5090998
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 PATIENT
Type of Report Initial
Report Date 11/08/2019
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2019
Is This An Adverse Event Report? No
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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