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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Burning Sensation (2146); Reaction (2414)

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.

• Brand Name: C-QUR MESH COATED WITH OMEGA-3 FISH OIL 7.5 X 12 CM
• Type of Device: COATED HERNIA MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth dr.; hudson NH 03051 492
• MDR Report Key: 2394781
• MDR Text Key: 2371055
• Report Number: MW5023636
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 12/28/2011
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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