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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.
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Brand NamePROLENE MESH 15X15
Type of DeviceHERNIA MESH
Manufacturer (Section D)
MDR Report Key2650980
MDR Text Key2872440
Report NumberMW5026078
Device Sequence Number2
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
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 Received07/05/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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