Description of Event or Problem · 1
CHOKED [CHOKING] TOOTHBRUSH BRISTLES IN MOUTH [PRODUCT COMPLAINT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA LOCAL AFFILIATE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH MILK TEETH TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED AQUAFRESH MILK TEETH TOOTHBRUSH AT AN UNKNOWN DOSE FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING AQUAFRESH MILK TEETH TOOTHBRUSH, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH AQUAFRESH MILK TEETH TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND PRODUCT COMPLAINT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING AND PRODUCT COMPLAINT TO BE RELATED TO AQUAFRESH MILK TEETH TOOTHBRUSH. AE REPORTED BY MALE MOP'S MOTHER WHO SENT AN EMAIL REFUSING CONSENT TO FOLLOW UP WITH HER SON'S HCP ((B)(6)). THE REPORTER SUBSEQUENTLY MENTIONED A FEMALE THAT EXPERIENCED AN AE WITH AQUAFRESH MILK TEETH TOOTHBRUSH. THE REPORTER STATED THE FOLLOWING: "THE BRISTLES IN THE TOOTHBRUSH CAME OUT IN HIS MOUTH. HE CHOKED AND I STUCK MY FINGERS IN AND GOT THEM OUT. SINCE THIS OBSCURED I POSTED IT ON (B)(6) AND WARNED OTHER MOTHERS OF THIS PRODUCT AND ONE OF MY FRIENDS TOLD ME THE SAME HAPPENED TO HER LITTLE GIRL." NO FURTHER INFORMATION AVAILABLE.