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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD SHANNON LIMITED BARD COMPOSIX LP MESH 6 X 8 MESH, SURGICAL POLYMERIC

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BARD SHANNON LIMITED BARD COMPOSIX LP MESH 6 X 8 MESH, SURGICAL POLYMERIC Back to Search Results
Model Number 0134580
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Hernia (2240)
Event Date 08/12/2019
Event Type  Injury  
Event Description
I had extreme pain in my abdomen at work and took off the job. I ran to my doctors office who told me to go to an emergency ct scan. The scan showed a massive hernia due to mesh failure. I then was told to go to an emergency room, they did another ct scan and didn't want me to leave the er all holiday weekend until i was to have surgery. I decided to wait to see my surgeon who implanted the bard composix lp mesh in 2009. The following monday 3 days after the er. Revision surgery was scheduled asap with my surgeon and his partner a master surgeon to remove the failed mesh. After 8 days in the hospital and having a full open surgery worse than any i have ever had. I am still not able to work after 3 months. My career is over. I may wind up disabled. It has been very painful at times through the years. Incontinence, painful sex, fevers, pain, bleeding, irregular bm, and more. No one but me pointed to the mesh and i was told it was probably something else. Bard composix lp with echo ps a positioning balloon was a class 2 recall. Why is the same mesh without not recalled? this mesh has worse coating on it. Eptfe i ordered sticker page from medical records and found more info after researching. Permanent coating numerous bard hernia meshes include expanded polytetetrafluoroethylene (eptfe) in their design, such as the composix kugel, composix lp, composix ex, ventralex, and ventrio hernia meshes. Eptfe is known to contact at an even faster rate than polypropylene. As a result, the mesh begins to curl and deform as the eptfe shrinks post implantation. Additionally, eptfe breaks down in the presence of bacteria. As eptfe breaks down, it creates small nooks and crannies that harbor bacteria and protect the bacteria from the bodies defense system. That bacteria can then form what is known as a biofilm and cause long term and systemic infections. Eptfe also increases the permanent foreign body load, creating an even greater immune response to the hernia mesh implant. The increased immune response then causes the polypropylene to degrade at an even faster rate. The fda has not recalled this device? i find this absurd. Chronic pain is all that is left besides an 11 inch track from staples and who knows what next. Fda safety report id# (b)(4).
 
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Brand NameBARD COMPOSIX LP MESH 6 X 8
Type of DeviceMESH, SURGICAL POLYMERIC
Manufacturer (Section D)
BARD SHANNON LIMITED
MDR Report Key9341356
MDR Text Key167175842
Report NumberMW5091153
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 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2014
Device Model Number0134580
Device Lot NumberHUTE1283
Was Device Available for Evaluation? No
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: 11/18/2019 Patient Sequence Number: 1
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