DURAPORE SILK TAPE 1X10YDS

Description of Event or Problem

EVENT DESCRIPTION: A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT AN ISSUE AGAINST THE DURAPORE SILK TAPE 1" X 10YDS. THE PATIENT STATED THE SILK TAPE WAS VERY STICKY WHEN SHE PULLED IT OFF HER STOMACH IT WAS PULLING HER SKIN CAUSING BLEEDING AND REDNESS, SHE WANTED TO TRY THE SURGICAL TAPE OR ALT TAPE. THE LAST TAPE SHE USED TAPE WAS TWO WEEKS AGO. THE PATIENT INVOLVEMENT WAS UNKNOWN, HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).