Description of Event or Problem · 1
SWALLOWING OF TOOTHBRUSH COMPONENTS. PRODUCT COMPLAINT. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SWALLOWING OF TOOTHBRUSH COMPONENTS IN A (B)(6) FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH (AQUAFRESH LITTLE TEETH TOOTHBRUSH) TOOTHBRUSH FOR DRUG USE FOR UNKNOWN INDICATION. ON (B)(6) 2014, THE PATIENT STARTED AQUAFRESH LITTLE TEETH TOOTHBRUSH (DENTAL) AT AN UNK DOSE AND FREQUENCY. ON AN UNK DATE, AN UNK TIME AFTER STARTING AQUAFRESH LITTLE TEETH TOOTHBRUSH, THE PATIENT EXPERIENCED SWALLOWING OF TOOTHBRUSH COMPONENTS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNK DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. THE ACTION TAKEN WITH AQUAFRESH LITTLE TEETH TOOTHBRUSH WAS UNK. ON AN UNK DATE, THE OUTCOME OF THE SWALLOWING OF TOOTHBRUSH COMPONENTS WAS UNK AND THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNK. ADDL COMMENTS: THIS CASE WAS REPORTED BY THE MOTHER OF A (B)(6) GIRL WHO HAD BEEN USING AN AQUAFRESH LITTLE TEETH TOOTHBRUSH. SHE DESCRIBED AT APPROXIMATELY THREE TO FOUR WEEKS AFTER STARTING TO USE THE PRODUCT, SHE FOUND THAT THE RUBBER AT THE BACK OF THE TOOTHBRUSH HAD BEEN BREAKING UP AND HAD COMPLETELY DISINTEGRATED BECAUSE HER DAUGHTER USED TO CHEW THE TOOTHBRUSH. AS A RESULT OF THIS, HER DAUGHTER MAY HAVE SWALLOWED SOME OF THE PLASTIC, INCLUDING THE BRISTLES. NO BATCH NUMBER OR EXPIRY DATE INFO WAS PROVIDED.