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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM C-QUR MESH COATED WITH OMEGA 3 FISH OIL

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ATRIUM C-QUR MESH COATED WITH OMEGA 3 FISH OIL Back to Search Results
Event Date 01/07/2011
Event Type  Injury  
Event Description

Initially i had what was thought to be a "redo" of a right inguinal hernia repair which was successfully fixed in 2008. In (b)(6) 2011, i began to experience increasing pain in my right groin, radiating to my right labia but also experiencing shooting pain down the front of my right thigh. When i went to the operating room on (b)(6) 2011 an obturator hernia was found instead, with a peritoneal sac containing fluid present in my right thigh. The surgeon used c-qur mesh, coated with omega-3 fish oil to repair the hernia. I never recovered from this surgery, experiencing increasing burning and shooting pain first on the right side then progressing to the left side as well. I felt very sick and was taken back to the operating room in (b)(6) where the surgeon removed all of the atrium c-q-cur mesh, feeling that i was having a reaction to it. He said that when he opened me up it looked like a "bomb" went off inside of me - the mesh was floating freely in my abd/pelvic cavity; it had also become enmeshed in my appendix necessitating an appendectomy. After this surgery i never did recover; after multiple inpatient hospitalizations and er visits (at one point was down to 98 pounds and needed to be on tpn). My last surgery was in sept of this year; i had developed adhesions in the abd/pelvic and inguinal area, with only sutures left to repair my hernias. I also underwent a cholecystectomy due to adhesions. No i am left with chronic pelvic and abdominal pain; i have lost my job due to being out of work too long. Needless to say this whole ordeal has had tremendous impact not only on the quality of my life but my financial situation as well. In retrospect i wish i never had the first hernia repair done and had just let the chips fall where they may. I would never recommend c-qur mesh by atrium to anyone if this were in my domain and allowed. I have gone from being a high functioning rn to an unemployed per in chronic pain. I have had difficulty completing this report; for instance it required i entered that i died due to adverse effect, which obviously i did not; also required me to enter that it was a congenital problem and a reused product in order to proceed to the next product, which it was not.

 
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Brand NameC-QUR MESH
Type of DeviceCOATED WITH OMEGA 3 FISH OIL
Manufacturer (Section D)
ATRIUM
MDR Report Key2348594
Report NumberMW5023207
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/20/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/20/2011 Patient Sequence Number: 1
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