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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL BARD COMPOSIX E/X MESH
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DAVOL BARD COMPOSIX E/X MESH Back to Search Results
Catalog Number 0123460
Device Problems Material Deformation (2976); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Adhesion(s) (1695); Adhesion(s) (1695); Pain (1994); Pain (1994); Tissue Damage (2104); Obstruction/Occlusion (2422); Obstruction/Occlusion (2422); No Code Available (3191); No Code Available (3191)
Event Date 01/07/2006
Event Type  Injury  
Event Description
Bard composix e/x mesh (lot # 43fpd274).My wife had hernia repair surgery in 2007 and was implanted with a bard composix e/x mesh on her right abdominal side.Since she had that surgery she has had multiple upon multiple bowel obstructions over the years, of which included 4-5 hospital visits, one that lasted 8 days, another that lasted about 4-5 days, and the most recent, ((b)(6) 2015) she was admitted with the worst bowel obstruction yet, 2 days later the doctors decide to go in and remove the bard composix e/x mesh which had contracted inside her and adhered to her small bowel in which the doctor had to do a small bowel resection as well to free up her bowel from the mesh.Notably, this most recent bowel obstruction was not improving after about a 48 hour period and her stomach/abdomen was getting harder and harder.Given the fact that my wife has gone through so much pain and trauma in an 8 year period and the main reason being this implanted mesh, it makes total sense for the fda to recall this product now without delay so this does not happen to another person again.Seeing my wife go through so much pain and suffering over the years, has been very difficult.We have full reports and hospital records of what occurred and when.
 
Event Description
Add'l info received from reporter on 03/06/2017 report mw5062433: my wife has been through the most unimaginable pain and suffering for the last 10 years and most recently the last 2 years in which her health continues to decline and she is having neurological problems along with many other health problems all of which did not exist before 2006 before the initial implantation of the e/x mesh.This product needs to be recalled immediately and never used again.Anything with polypropylene should not be put into the human body for any reason.The doctor described the mesh to me as it was "crumpled up" inside of her.In all these years of being in and out of the hospital and seeing the pain and suffering in my poor wife has been through, i am asking that this is taken to the highest level of importance in having this device recalled immediately so this doesn't happen again to someone else.Ten years is long to have to go through what we have and the health deterioration my life is experiencing on a daily basis.Thank you very much for your time in this matter and i hope to see that it is officially recalled by the fda fast.
 
Event Description
Bard composix e/x mesh (lot # 43fpd274).My wife had hernia repair surgery in 2007 and was implanted with a bard composix e/x mesh on her right abdominal side.Since she had that surgery she has had multiple upon multiple bowel obstructions over the years, of which included 4-5 hospital visits, one that lasted 8 days, another that lasted about 4-5 days, and the most recent, ((b)(6) 2015) she was admitted with the worst bowel obstruction yet, 2 days later the doctors decide to go in and remove the bard composix e/x mesh which had contracted inside her and adhered to her small bowel in which the doctor had to do a small bowel resection as well to free up her bowel from the mesh.Notably, this most recent bowel obstruction was not improving after about a 48 hour period and her stomach/abdomen was getting harder and harder.Given the fact that my wife has gone through so much pain and trauma in an 8 year period and the main reason being this implanted mesh, it makes total sense for the fda to recall this product now without delay so this does not happen to another person again.Seeing my wife go through so much pain and suffering over the years, has been very difficult.We have full reports and hospital records of what occurred and when.
 
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Brand Name
BARD COMPOSIX E/X MESH
Type of Device
BARD COMPOSIX E/X MESH
Manufacturer (Section D)
DAVOL
MDR Report Key5675310
MDR Text Key45977187
Report NumberMW5062433
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 03/06/2017
1 Device was Involved in the Event
2 Patient was Involved in the Event
Date FDA Received05/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/30/2010
Device Catalogue Number0123460
Device Lot Number43FPD274
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age44 YR
Patient Weight54
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