SURGIMESH XB

Description of Event or Problem

PATIENT HAD AN OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2015 WITH SURGIMESH XB TINTRA E-1522. THE ABDOMINAL WALL INCISION NEVER HEALED AND OPENED UP. ON (B)(6) 2015 ANOTHER DOCTOR AT THE (B)(6) MEDICAL CENTER DID AN OPEN EXPLORATORY LAPAROPTOMY TO DEBRIED AND IRRIGATE THE WOUND IN AN ATTEMPT TO CLEAR UP THE INFECTION. ON (B)(6) 2015 A SECOND AND THIRD OPEN EXPLORATORY LAPAROTOMY WAS PERFORMED TO IRRIGATE AND DEBRIED THE WOUND. DURING THE FINAL IRRIGATION AND DEBRIEDMENT THE TINTRA E-1522 WAS REMOVED. PER HOSPITAL POLICY THE TINTRA E-1522 WAS KEPT AT THE HOSPITAL AND FINALLY DISPOSED OF. THE STERILITY AND ACCEPTABILITY FOR CLINICAL USE OF THE SURGIMESH XB TINTRA E-1522 WAS CONFIRMED THROUGH THE MANUFACTURER LOT HISTORY RECORDS.