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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH COATED WITH OMEGA-3 FISH OIL 7.5 X 12 CM COATED HERNIA MESH

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ATRIUM MEDICAL CORPORATION C-QUR MESH COATED WITH OMEGA-3 FISH OIL 7.5 X 12 CM COATED HERNIA MESH Back to Search Results
Event Date 01/07/2011
Event Type  Injury  
Event Description

Atrium c-qur mesh implanted in me for obturator hernia repair. Back to er 6 hours after discharge for pain (b)(6) in area of mesh implantation near bladder. Never recovered from initial surgery, constant burning severe pain despite pain med. Md felt i was having a reaction or rejection to the mesh; back to operating room (b)(6) 2011; surgeon said abd and pelvic area looked "like a bomb went off" and area very red and irritated "like a 3rd degree burn. " mesh removed -what he was able to (told my husband some strands were not able to be removed) also appendix was involved with mesh which was floating freely/not attached per surgeon and appendix had to be removed. Operating room (b)(6), (b)(6) 2011 for lysis of adhesions and cholecystectomy. Am now left w/chronic lower abd/pelvic pain which is not relieved with medication; also tried nerve blocks x3 and acupuncture with no significant change in pain. Now unemployed due to being out of work too long (most of 2011) and am too weak/deconditioned to stand for any length of time; sitting exacerbates pain (previous job required sitting at a computer). Medtronic epidural nerve stimulator has been proposed; however, at this pont, i am hesitant to undergo yet another invasive procedure which may or may not help. If i had known the surgery would result in my rejection/reaction to this mesh, which has changed my life in many negative ways, i would never had undergone it and would advise anyone considering hernia repair to look into the type of mesh that will be used. Definitely don't use c-qur mesh coated with omega-3 fish oil. I had a bilateral inguinal hernia repair in 2008 with no complications; a different mesh was used at that time. Now i have both inguinal hernias as well as the obturator hernias held together with sutures only, so am at increased risk of recurrence and limits the amount of weight i can safely lift (that is if i was strong enough to lift any weight). I had a total of 7 impatient stays and 3 er visits related to this pain this year. At one pont was down to (b)(6) on tpn.

 
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Brand NameC-QUR MESH COATED WITH OMEGA-3 FISH OIL 7.5 X 12 CM
Type of DeviceCOATED HERNIA MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
5 wentworth dr.
hudson NH 03051 492
MDR Report Key2394781
Report NumberMW5023636
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 12/28/2011 Patient Sequence Number: 1
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