BIONIX OTOCLEAR EAR IRRIGATION SYSTEM

Description of Event or Problem

BIONIX OTOCLEAR EAR IRRIGATION SYSTEM, PRODUCT #7280, INCLUDES A WATERPIK WATER FLOSSER, MODEL WP-440, THAT CONTAINS A PACKAGE INSERT WITH TWO WARNINGS ON PAGE 3 TO NOT USE IN EARS. THE WARNINGS READ, "DO NOT DIRECT WATER UNDER THE TONGUE, INTO THE EAR, NOSE, OR OTHER DELICATE AREAS. THIS PRODUCT IS CAPABLE OF PRODUCTING PRESSURES THAT MAY CAUSE SERIOUS DAMAGE IN THESE AREAS", AND "DO NOT DIRECT WATER INTO THE NOSE OR EAR. THE POTENTIALLY DEADLY AMOEBA, NAEGLERIA FOWLERI, MAY BE PRESENT IN SOME TAP WATER OR UNCHLORINATED WELL WATER AND MAY BE FATAL IF DIRECTED INTO THESE AREAS". THIS PRODUCT IS NOT COMPOUNDED OR AN OVER-THE COUNTER.