MAUDE Adverse Event Report: MESH

Device Problem Kinked (1339)

Patient Problems Perforation (2001); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 06/01/2016

Event Type  Injury  

Event Description

I thought i had food poisoning.I did not go to hospital for 3 days.I threw up my dessert, but not dinner.Then i couldn't even keep a teaspoon of water down.I was admitted 3 days later, had a nasal tube put in , and had surgery on the 7th or 8th day for upper bowel obstruction.Mesh used for bladder prolapse one year earlier got a piece of my upper intestine "stuck on it" causing the intestine to kink not allowing anything to pass thru.During surgery my intestine was perforated in 2 small places so i became very high risk at that point.I was in hospital for 13 days and lost 2 months at work.I went back to the specialist who did the bladder surgery and he said he had never heard of anything like it.I will never be the same, and i'm terrified it will happen again because i never had such a large surgical scar and i'm terrified of the adhesions causing further issue.There were adhesions found from the laparoscopic surgeries i've had.I don't ever want this to happen to anyone else!!.

• Brand Name: MESH
• Type of Device: MESH
• MDR Report Key: 6604670
• MDR Text Key: 76536920
• Report Number: MW5070127
• 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: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 56 YR
• Patient Weight: 64