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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MESH

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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!!.
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Brand NameMESH
Type of DeviceMESH
MDR Report Key6604670
MDR Text Key76536920
Report NumberMW5070127
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
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 Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 05/30/2017 Patient Sequence Number: 1