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

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.

• Brand Name: HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 9310591
• MDR Text Key: 166222499
• Report Number: MW5090998
• Device Sequence Number: 2
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1