MAUDE Adverse Event Report: MESH

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 01/01/2002

Event Type  Other  

Event Description

Dear sir, i am writing concerning a surgery i had in 2002. It was a hernia, done with mesh. I am still experiencing bad complications after all these years. I get pangs that feel like a bowie knife stabbing. I can't get off the toilet sometimes because of pain, and difficulty walking when flare up happens. Am i the only one having these issues? if not, is there anything being done on our behalf? thank you for your time and effort.

• Brand Name: MESH
• Type of Device: MESH
• MDR Report Key: 6043152
• MDR Text Key: 58060154
• Report Number: MW5065513
• Device Sequence Number: 1
• Product Code: FTL
• 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: 10/19/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• 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?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage