MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM C-QUR 4" X 6" HERNIA MESH

Lot Number 10740287017

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Discharge (2225)

Event Date 09/05/2011

Event Type  Injury  

Event Description

On (b)(6) 2011, pt was implanted for incisional hernia repair with the atrium c-qur polypropylene surgical mesh with omega 3 fatty acid bio-absorbable coating. After much pain and swelling around incision site for 9 weeks, additional surgery took place on (b)(6) 2011 to remove atrium c-qur mesh. Fatty acid coating came off in a few weeks and left bare polypropylene surgical mesh in contact with otherwise healthy tissue and caused a significant foreign body reaction and inflammation and a "cottage cheese like substance", not infection, which surrounded the mesh. Mesh never allowed healing, as per surgeon's statement and surgical report. Mesh fractured, as per surgeons statement. Mesh was "very, very poorly incorporated" as per surgeons statement and surgical report. Previously otherwise healthy tissue was removed, including previously healthy muscle tissue was removed because of damage done by atrium c-qur. Because of -previously healthy- tissue removal surrounding the atrium c-qur, surgeon was left with only option to perform a retro rectus repair implanting 15x15 ethicon prolene mesh. Subsequent life threatening infection, prolonged hospitalization, then 6 weeks of home iv infusion of vancomycin, additional 5 weeks of oral vancomycin. Third surgery is now required to remove ethicon prolene mesh. Pt is now and has been on heavy pain medication since (b)(6) 2011, has additional numerous health problems which arose after implant of atrium c-qur.

• Brand Name: ATRIUM C-QUR 4" X 6"
• Type of Device: HERNIA MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 2650980
• MDR Text Key: 2872440
• Report Number: MW5026078
• 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: 07/05/2011
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2012
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/01/2014
• Device Lot Number: 10740287017
• Other Device ID Number: REFERENCE # 34528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 07/05/2012 Patient Sequence Number: 1