CONVATEC LOOP OSTOMY ROD

Description of Event or Problem

THIS CASE WAS DISCOVERED DURING THE ANALYSIS OF MALFUNCTION REPORT 1049092-2005-00030 WHICH WAS SUBMITTED IN 05/2005. THAT CASE MENTIONED THE OCCURRENCE OF THIS EVENT WHICH WAS NOT PREVIOUSLY REPORTED TO CONVATEC. NURSE STATED THIS EVENT OCCURRED "WITHIN THE PAST YEAR". THE SWIVEL TIP SEPARATED FROM THE ROD WHILE THE ROD WAS SUTURED IN PLACE. THE PT'S ABDOMEN HAD BECOME VERY DISTENDED AND THE ROD CAME APART. NURSE STATED THAT IT WAS NOT CONSIDERED AN ISSUE AT THE TIME AND, AS A RESULT, WAS NOT REPORTED TO CONVATEC.