AFT - 1 DIVERTED TUBE
Received Jun 21, 2010 · Event occurred May 24, 2010
Report 2249062-2010-00006 · MDR key 1744612
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Purulent Discharge
- Inflammation
Narrative
Additional Manufacturer Narrative
SEE MEDWATCH #'S 2249062-2010-00005, 2249062-2010-00007.
Description of Event or Problem
THE PATIENT ARRIVED FOR SURGERY ON (B)(6) 2010; HIS BACK EXHIBITING AN AREA OF SWELLING. THE SURGEON PROCEEDED TO USE SUCTION TO REMOVE THE FLUID, EXTRUDED THE 3 TUBES OF AFT INTO A MESH BAG, AND IMPLANTED THE MESH BAG INTO THE PATIENT'S BACK. FOLLOWING SURGERY, THE PATIENT'S BACK BECAME INFLAMED AGAIN AND HE UNDERWENT SURGERY THE WEEK OF (B)(6) 2010. THE WOUND SITE WAS DESCRIBED AS "INFLAMED WITH PUS AND THE INFECTION ATE AWAY ALL OF THE BONE". THE SURGEON REMOVED THE EMPTY MESH BAG AND PLACED THE PATIENT ON ANTIBIOTICS. IT WAS REPORTED THAT "THE SURGEON BELIEVES THAT THE PATIENT ALREADY HAD THE INFECTION PRIOR TO SURGERY; THAT IT WAS NOT CAUSED BY AN MTF PRODUCT". ADDITIONAL INFORMATION HAS BEEN REQUESTED; NOT YET RECEIVED.