FDA Adverse Event Injury Summary report: N

C-QUR HERNIA PATCH

MDR report key: 2462535 · Received February 13, 2012

Report

Report Number
MW5024267
Event Type
Injury
Date Received
February 13, 2012
Date of Event
September 4, 2011
Report Date
February 13, 2012
Manufacturer
ATRIUM MEDICAL
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD AN ATRIUM C-QUR HERNIA PATCH PUT IN ON (B)(6) 2011 AND THE PATCH DISSOLVED AND NEVER STARTED TO HEAL. I HAD TO HAVE ANOTHER SURGERY ON (B)(6) 2011 TO REMOVE WHAT WAS LEFT OF THE C-QUR HERNIA PATCH MADE BY ATRIUM MEDICAL. MY DOCTOR (B)(6) SAID THE PATCH DISSOLVED AND NEVER STARTED TO HEAL SO HE HAD TO COMPLETELY DISSECT ME TO REMOVE IT. AS A RESULT OF THIS SECOND SURGERY, I GOT (B)(6), SO THE PATCH FAILED AND IS DEFECTIVE. MY DOCTOR (B)(6) AT (B)(6) SURGICAL CENTERS HERE IN (B)(6) SAID THE PATCH IS DEFECTIVE AND WAS AT A MEDICAL CONFERENCE AND HE SAID THERE WERE OTHER DOCTORS THERE WHO ARE HAVING THE SAME PROBLEM WITH THIS PATCH, IT DISSOLVES IN PTS AND HAS TO BE REMOVED. YOU GUYS, THE FDA, MADE ATRIUM MAKE CHANGES TO THIS C-QUR PATCH BEFORE YOU PASSED IT. THE PATCH IS MADE OF POLYPROPYLENE AND ALSO HAS FISH OIL IN IT. THE PROBLEM WITH POLYPROPYLENE IS OUR BODIES ARE MADE UP OF MOSTLY WATER AND POLYPROPYLENE BREAKS DOWN IN A WET ENVIRONMENT SO THEIR SOLUTION (ATRIUM) WAS TO PUT FISH OIL IN PATCH BUT IT DID NOT WORK. OMEGA 3 FISH FATTY ACIDS. THE POINT IS THIS PATCH IS FAILING ALL ACROSS THE UNITED STATES AND WE DESPERATELY NEED YOUR HELP TO RECALL THIS C-QUR HERNIA PATCH BEFORE PEOPLE START DYING. PLEASE HELP US. AGAIN THE PATCH IS A HERNIA PATCH MADE BY ATRIUM MEDICAL. ITS I.D IS C-QUR. THIS IS A BAD PATCH AND NEEDS TO BE REMOVED FROM THE MARKET. I HAVE ALL KINDS OF MEDICAL ISSUES DUE TO THIS PATCH FROM FAILING. THE PARTICLES ARE ALL OVER IN MY STOMACH CAVITY. MY DOCTOR SAID WHEN HE OPENED ME BACK UP IT LOOKED LIKE CLUMPS OF YELLOWISH COTTAGE CHEESE AND HE HAS PULLED IT FROM HIS PATCH SUPPLIES AND SO HAS COUNTLESS OTHER DOCTORS. PLEASE HELP. MY NAME IS (B)(6). THANK YOU FOR YOUR ATTENTION TO THIS HUGE PROBLEM. THANK YOU, (B)(6). I JUST SUBMITTED A COMPLAINT ABOUT ATRIUM MEDICAL HERNIA PATCH AND I PUT THE WRONG I.D LETTERS IN IT IS THE C-QUR HERNIA PATCH NOT CQVR I HAD A VENTRICLE HERNIA REPAIR ON (B)(6) 2011 AND THE ABOVE NAMED PATCH DISSOLVED. IT NEVER ADHERED AND DISSOLVED AND I GOT A (B)(6) INFECTION FROM PIECES OF PATCH IN MY ABDOMEN CAVITY, MY DOCTOR PULLED THIS PATCH THE CQUR MADE BY ATRIUM MEDICAL AND HE SAID OTHER DOCTORS ACROSS U.S ARE HAVING SAME BAD RESULTS WITH THIS PATCH. IT'S DEFECTIVE AND NEEDS TO BE RECALLED BEFORE SOMEONE DIES! MY DOCTOR (B)(6) HERE IN (B)(6) SAID HE WAS JUST AT A MEDICAL CONFERENCE AND DOCTORS ALL OVER AND PTS ARE HAVING THE SAME PROBLEM AND HAVE PULLED IT FROM THEIR STOCK OF HERNIA PATCHES. THE PATCHES MADE UP FROM POLYPROPYLENE AND OMEGA 3 FISH OILS. THE PROBLEM IS THE PATCH THE POLYPROPYLENE IS NOT MADE TO BE IN A WET ENVIRONMENT AND SINCE OUR BODIES ARE MADE UP OF MOSTLY WATER THEY DISSOLVE! MINE DID NOT LAST EVEN A MONTH AND PEOPLE ARE POPPING UP EVERYWHERE SAYING AS SHORT AS TWO WEEKS. THIS PATCH IS HORRIBLE AND NEEDS TO BE RECALLED ASAP. STILL UNDER DOCTOR (B)(6) CARE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 C-QUR HERNIA PATCH HERNIA PATCH FTL ATRIUM MEDICAL UNK
2 C-QUR ATRIUM HERNIA PATCH HERNIA PATCH FTL CQUR

Patients

Seq Age Sex Outcome Treatment
1 43 YR Hospitalization| L| O