COLGATE MINIONS POWER TOOTHBRUSH
Received Sep 23, 2016 · Event occurred Aug 31, 2016
Report 3005607635-2016-00020 · MDR key 5973019
Device
Generic name
Toothbrush
Product problems
- Break
- Detachment Of Device Component
Patient
24 MO
- Laceration(s)
- Pain
- Laceration(s)
- Pain
Narrative
Description of Event or Problem
INITIAL INFORMATION WAS RECEIVED ON 31AUG2016 FROM A CONSUMER'S MOTHER. THIS 24 MONTH OLD FEMALE CONSUMER WAS USING A COLGATE MINIONS POWER TOOTHBRUSH ((B)(4)) WHEN THE TOOTHBRUSH HEAD SNAPPED OFF IN HER MOUTH EXPOSING A METAL PIECE WHICH CUT HER GUM. SHE ALSO EXPERIENCED PAIN AND A HARD TIME EATING. SHE BEGAN USING THE TOOTHBRUSH ON AN UNKNOWN DATE IN (B)(6) 2016, APPROXIMATELY THREE WEEKS PRIOR TO REPORTING. THE CONSUMER USED THE TOOTHBRUSH A HANDFUL OF TIMES IN THE PRESENCE OF HER MOTHER. SUBSEQUENTLY, SHE EXPERIENCED THE EVENTS ON THE MORNING OF (B)(6) 2016. SHE ALMOST CHOKED ON THE BRUSH HEAD AFTER IT BROKE INSIDE OF HER MOUTH. SHE RECEIVED FOUR STITCHES IN HER MOUTH ON THE SAME DAY AS THE EVENTS. THE TOOTHBRUSH WAS DISCONTINUED ON (B)(6) 2016. AT THE TIME OF THIS REPORT, THE EVENTS WERE ONGOING. FOLLOW-UP INFORMATION WAS RECEIVED ON 22NOV2016 FROM THE CONSUMER'S MOTHER. THE CONSUMER USED THE COLGATE MINIONS POWER TOOTHBRUSH A "HANDFUL" OF TIMES WHILE SHE WAS BEING TRAINED ON HOW TO BRUSH HER TEETH. ON (B)(6) 2016 AFTER THE TOOTHBRUSH SNAPPED OFF IN THE CONSUMER'S MOUTH, EITHER THE HEAD OR THE BASE WITH THE EXPOSED METAL CAUSED A CUT TO THE BACK OF HER MOUTH ON TOP. SHE WAS TAKEN TO THE EMERGENCY ROOM AT A LOCAL HOSPITAL WHERE SHE RECEIVED AN UNSPECIFIED TOPICAL NUMBING AGENT (DOSAGE UNKNOWN), AN UNSPECIFIED "SEDATIVE-LIKE" MEDICATION (DOSAGE UNKNOWN) TO KEEP HER CALM, SEVEN STITCHES AND TYLENOL (DOSAGE UNKNOWN) FOR PAIN RELIEF. AT THE TIME OF THIS REPORT, THE CONSUMER HAS RECOVERED FROM ALL OF THE EVENTS. THIS CASE IS REFERENCED AS (B)(4).
Description of Event or Problem
INITIAL INFORMATION WAS RECEIVED ON 31AUG2016 FROM A CONSUMER'S MOTHER. THIS (B)(6) OLD FEMALE CONSUMER WAS USING A COLGATE MINIONS POWER TOOTHBRUSH ((B)(4)) WHEN THE TOOTHBRUSH HEAD SNAPPED OFF IN HER MOUTH EXPOSING A METAL PIECE WHICH CUT HER GUM. SHE ALSO EXPERIENCED PAIN AND A HARD TIME EATING. SHE BEGAN USING THE TOOTHBRUSH ON AN UNKNOWN DATE IN (B)(6) 2016, APPROXIMATELY THREE WEEKS PRIOR TO REPORTING. THE CONSUMER USED THE TOOTHBRUSH A HANDFUL OF TIMES IN THE PRESENCE OF HER MOTHER. SUBSEQUENTLY, SHE EXPERIENCED THE EVENTS ON THE MORNING OF (B)(6) 2016. SHE ALMOST CHOKED ON THE BRUSH HEAD AFTER IT BROKE INSIDE OF HER MOUTH. SHE RECEIVED FOUR STITCHES IN HER MOUTH ON THE SAME DAY AS THE EVENTS. THE TOOTHBRUSH WAS DISCONTINUED ON (B)(6) 2016. AT THE TIME OF THIS REPORT, THE EVENTS WERE ONGOING.