MEDICHOICE

Description of Event or Problem

AS THE PRIVATE-LABEL DISTRIBUTOR AND INITIAL IMPORTER OF THE 69902 PERINEAL COLD PACK, (B)(4) RECEIVED A REPORT FROM A HOSPITAL THAT A "PATIENT IN LABOR AND DELIVERY WAS GIVEN A PERI COLD PACK TO USE ON HER FOREHEAD. ACCORDING TO PATIENT'S MOTHER THE ICE PACK BURST AND THE CONTENTS OF THE PRODUCT GOT INTO THE PATIENT'S EYES AND HER NEWBORN'S EYES." THE HOSPITAL CONFIRMED THAT THE EYES OF BOTH THE PATIENT AND THE NEWBORN WERE FLUSHED WITH WATER BY THE NURSE AFTER THE INCIDENT TO PREVENT THE CONTENTS FROM CAUSING DAMAGE TO THE EYE. AFTER FOLLOW-UP WITH THE HOSPITAL, IT WAS REPORTED TO THE NURSE THAT THE PACK BURST AFTER 10 MINUTES OF USE ON THE PATIENT'S FOREHEAD. NO FURTHER ACTIONS TAKEN TO TREAT THE PATIENT WERE REPORTED BY THE HOSPITAL.