COLGATE POWER TOOTHBRUSH 360
Received Mar 17, 2015 · Event occurred Mar 10, 2015
Report 3005607635-2015-00002 · MDR key 4617771
Device
Generic name
None
Product problems
- Detachment Of Device Component
- Crack
- Entrapment of Device
Patient
22 YR
- Suffocation
- Choking
Narrative
Description of Event or Problem
INITIAL INFO WAS RECEIVED ON (B)(6) 2015 FROM A NURSE. A (B)(6) YEAR OLD POLYDISABLED FEMALE PT USED COLGATE POWER TOOTHBRUSH 360 AND A PIECE OF THE BRUSH CRACKED OFF AND BECAME LODGED IN THE PATIENT'S THROAT CAUSING HER TO "SUFFOCATE" WITH "NO AIR" AND CHOKE. SHE BEGAN USING THE TOOTHBRUSH ONCE A DAY ON AN UNK DATE IN (B)(6) 2014 WITH ONE CHANGE OF THE REPLACEMENT HEAD. SUBSEQUENTLY, THE TOOTHBRUSH BROKE AND THE EVENTS OCCURRED ON (B)(6) 2015. THE NURSE INDICATED THAT "THE WHOLE BLUE PLASTIC PIECE CAME OUT OF THE BRUSH AND BECAME LODGED IN HER THROAT. AS SHE WAS DISABLED, SHE WAS UNABLE TO SPIT IT OUT." A HEALTHCARE PROFESSIONAL WAS ABLE TO USE THEIR HANDS TO REMOVE THE PIECE OF THE TOOTHBRUSH. THE TOOTHBRUSH WAS DISCONTINUED ON AN UNK DATE IN 2015. AT THE TIME OF THIS REPORT, THE PT HAD RECOVERED. (B)(4).
Additional Manufacturer Narrative
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