CATHETER, PERITONEAL

Description of Event or Problem

THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, DIANEAL THERAPY WAS WITHDRAWN. ON AN UNREPORTED DATE ON (B)(6) 2012 THE PATIENT WAS HOSPITALIZED WITH PERITONITIS. ON AN UNREPORTED DATE, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. THE RESULTS OF THE CULTURE WERE UNKNOWN. THE PERITONITIS WAS CAUSED BY A HOLE IN THE CATHETER. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. THE PATIENT REMAINED HOSPITALIZED WITH OTHER MEDICAL PROBLEMS. PATIENT INJURY REPORTED: YES. MEDICAL INTERVENTION REQUIRED: YES (B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).