SURGIMESH XB

Description of Event or Problem

ON (B)(6) 2015, THE PATIENT HAD AN OPEN VENTRAL HERNIA REPAIR. ABOUT 4 WEEKS AFTER THE REPAIR, THE PATIENT SHOWED A SMALL WOUND BREAKDOWN AT THE INCISION SITE. ON (B)(6), FOLLOWING AN OUTPATIENT CT SCAN, THE PATIENT WAS ADMITTED FOR AN INTRA-ABDOMINAL FLUID COLLECTION. THE FOLLOWING DAY THE FLUID COLLECTION WAS ASPIRATED, A DRAIN PLACED AND IV ANTIBIOTICS ADMINISTERED. THE XB TINTRA E-2226 USED WAS CONFIRMED STERILIZED THROUGH REVIEW OF MANUFACTURER STERILIZATION RECORDS. SUBSEQUENTLY ON (B)(6), THE PATIENT DEMONSTRATED PURULENT DRAINAGE FROM THEIR ABDOMINAL WALL. THE PATIENT WAS BROUGHT BACK TO SURGERY, THEIR ABDOMINAL WALL CLEANED UP AND A WOUND VAC PLACED. THREE ADDITIONAL INTERVENTIONS WERE NECESSARY TO CLEANUP THE INFECTION. AT LAST FOLLOW-UP, THE PATIENT WAS CONVERTED TO BLACK DRAINS WITH NO ADDITIONAL FOLLOW-UP INFORMATION AVAILABLE. THE SURGIMESH XB TINTRA E-2226 REMAINED IN THE PATIENT.