K-Y TOUCH MASSAGE 2 IN 1 WARMING

Description of Event or Problem

CONSUMER'S MOTHER REPORTS (B)(6) SON ADMITTED TO EMERGENCY ROOM WITH ALLERGIC REACTION. CONSUMER SUFFERED A SEVERE ALLERGIC REACTION (ANAPHYLAXIS) AFTER APPLICATION OF THE PRODUCT TO BODY. IT IS UNKNOWN IF THE CONSUMER HAS ANY PREVIOUS ALLERGIES. THE APPLICATION OF THE PRODUCT TO THE WHOLE BODY MAY HAVE CONTRIBUTED TO THE SEVERITY OF THE REACTION LEADING TO HIS HOSPITAL ADMISSION. DISORIENTATION, CONFUSION AND DIZZINESS CAN OCCUR IN ANAPHYLACTIC REACTIONS AND IS NOT UNEXPECTED. THE INTRODUCTION OF A SALINE DRIP IS STANDARD PROCEDURE TO HELP PREVENT SHOCK. THE LACK OF EFFECT BY THE PHENERGAN ANTIHISTAMINE IS ALSO NOT UNEXPECTED AS ANAPHYLAXIS CAN BE DIFFICULT TO MANAGE.

Additional Manufacturer Narrative

THIS EVENT IS FROM A CONSUMER IN AUSTRALIA. THE PRODUCT WAS DISCONTINUED IN 2008, SO IT IS HIGHLY PROBABLY THE PRODUCT USED WAS PAST ITS EXPIRY DATE. DATE OF THIS SUBMISSION IS (B)(4) 2010. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL SIGNIFICANT INFO IS RECEIVED.