COLGATE 360 BATTERY POWERED TOOTHBRUSH
Received Dec 18, 2014 · Event occurred Nov 26, 2014
Report 3005607635-2014-00049 · MDR key 4360167
Device
Generic name
Toothbrush
Lot number
1464LE
Product problems
- Detachment Of Device Component
Patient
42 YR
- Dysphagia/ Odynophagia
- Dysphasia
- Choking
Narrative
Description of Event or Problem
INITIAL INFORMATION WAS RECEIVED ON (B)(6) 2014 FROM A CONSUMER'S MOTHER. THIS (B)(6) YEAR OLD MALE CONSUMER WITH A HISTORY OF CEREBRAL PALSY USED A COLGATE 360 BATTERY POWERED TOOTHBRUSH WITH THE ASSISTANCE OF HIS AIDE AND THE "SECOND PART OF THE HEAD" CAME OFF, HE SWALLOWED THE HEAD AND IT BECAME STUCK IN HIS THROAT. AS A RESULT, THE CONSUMER'S VOICE SOUNDED HOARSE AND HE HAD TROUBLE SWALLOWING FOR A COUPLE OF DAYS. HE BEGAN USING THIS TOOTHBRUSH A FEW MONTHS PRIOR TO THIS REPORT ON AN UNSPECIFIED DATE IN 2014, USING ONCE DAILY IN THE MORNING. SUBSEQUENTLY, HE EXPERIENCED THE EVENTS ON (B)(6) 2014. THE CONSUMER'S MOTHER REPORTED THAT HE DID NOT EXPERIENCE ANY DISTRESS, NO COUGHING OR CHOKING. HOWEVER, THE CONSUMER, WHO IS NON VERBAL AND HAS THE MENTALITY OF A ONE YEAR OLD, LOOKED AT HER WITH A "PLEASE HELP ME" LOOK. WHEN THE MOTHER LOOKED DOWN THE CONSUMER'S THROAT, SHE COULD SEE THE HEAD OF THE TOOTHBRUSH. AS TREATMENT, SHE TOOK THE CONSUMER TO THE HOSPITAL WHERE HE UNDERWENT SURGERY TO REMOVE THE TOOTHBRUSH HEAD. THE CONSUMER WAS DISCHARGED THAT SAME DAY WITH INSTRUCTIONS TO EAT A SOFT DIET AND WAS WARNED OF A POSSIBLE SORE THROAT. USE OF THE TOOTHBRUSH WAS DISCONTINUED ON (B)(6) 2014 AND AFTER 48 HOURS, THE EVENTS HAD RESOLVED. THIS CASE IS REFERENCED AS (B)(4).
Additional Manufacturer Narrative
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