#5 ABRA BUTTON ANCHOR

Description of Event or Problem

THE PT IS A (B)(6) MALE WHO WAS TRANSFERRED TO (B)(6) WITH A DIAGNOSIS OF NECROTIZING PANCREATITIS. THE PT UNDERWENT A LAPAROTOMY AND DEBRIDEMENT OF NECROTIZING PANCREATITIS ON (B)(6) 2009, THAT RESULTED IN AN OPEN ABDOMEN. THE PT WAS ENROLLED INTO THE (B)(4) STUDY, AND THE ABRA DEVICE WAS PLACED ON (B)(6) 2009. A MASS AMOUNT OF DRAINAGE AND INFECTION, ALONG WITH THE ABSENCE OF WOUND EDGE APPROX FOR GREATER THAN THREE DAYS REQUIRED ABRA DEVICE REMOVAL. ON (B)(6) 2009, FOLLOWING ABRA DEVICE REMOVAL, TWO JACKSON PRATT DRAINS WERE PLACED WHERE THE PANCREATIC DRAINAGE OCCURRED, ALONG WITH PLACEMENT OF A WOUND VAC SYSTEM. DURING THE PROCEDURE IT WAS NOTED THAT SOFT TISSUE DEBRIDEMENT WAS NEEDED ON THE SKIN WHERE THE ABRA DEVICE BUTTON PADS PREVIOUSLY RESTED. THE DEBRIDED AREAS WERE COVERED WITH THE WOUND VAC SPONGE AND WERE CONTAINED UNDER THE WOUND VAC DRESSING. THE EVENT WAS REVIEWED BY THE SITE APPROVED DATA SAFETY MONITORING BOARD AND THE EVENT WAS REPORTED TO THE LOCAL (B)(6) ON (B)(6) 2009. IT WAS NOTED DURING AN INTERNAL AUDIT THAT THE EVENT HADN'T BEEN REPORTED TO THE SPONSOR. THIS WAS AN OVERSIGHT AND ONCE NOTICED THE REPORT WAS PROMPTLY SUBMITTED.

Additional Manufacturer Narrative

EVAL OF THE EVENT WAS COMPLETED THROUGH REVIEW OF THE PT'S RECORD WITH THE SURGEON, DR (B)(6), WHO BELIEVES THERE WAS NO DEVICE FAILURE, AND THAT THE PT'S OVERALL FRAGILE CONDITION PRE-DISPOSED HIM TO SKIN ULCERATION UNDER THE BUTTON ANCHORS. IT CANNOT BE DETERMINED IF MAINTENANCE INSTRUCTIONS TO CLEAN AND DRY UNDER THE BUTTONS EVERY 12 HRS (AS SPECIFIED IN THE INSTRUCTIONS FOR USE) WERE FOLLOWED TO PREVENT SKIN BREAKDOWN.