ORAL-B COMPLETE ACTION POWER TOOTHBRUSH

Additional Manufacturer Narrative

(B)(4) 2015 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED TOOTHBRUSH HANDLE AND 1 TOOTHBRUSH HEAD ON (B)(6) 2015. PRODUCT INVESTIGATION REVEALED CAUSE OF FAILURE TO BE EXCESSIVE WEAR DUE TO PROLONGED USE. NO MANUFACTURING OR DESIGN CAUSE IDENTIFIED.

Description of Event or Problem

PAIN - INNER CHEEK [ORAL PAIN]. STABBED/PUNCTURED INNER CHEEK [MOUTH INJURY]. BRUSHHEAD FELL OFF TOOTHBRUSH EXPOSING METAL SHAFT / BRUSH HEAD FELL OFF IN MOUTH [DEVICE BREAKAGE]. METAL SHAFT STABBED INNER CHEEK AND PUNCTURED IT [INJURY ASSOCIATED WITH DEVICE]. CASE DESCRIPTION: A (B)(6) MALE CONSUMER REPORTED THAT HE HAD BEEN USING AN ORAL-B COMPLETE ACTION POWER TOOTHBRUSH, 2-3 TIMES A DAY, AND THE ORAL-B BRUSHHEAD, VERSION UNKNOWN FELL OUT IN HIS MOUTH. HE STATED THAT HE REPLACED THE BRUSHHEAD, BUT THE SECOND BRUSHHEAD FELL OFF IN HIS MOUTH AGAIN, AND THE METAL SHAFT OF THE TOOTHBRUSH STABBED HIM IN HIS INNER CHEEK/JAW AND PUNCTURED IT. HE EXPERIENCED PAIN-INNER CHEEK AS A RESULT. HE RINSED HIS MOUTH OUT WITH ANTISEPTIC MOUTHWASH AND REPORTED THAT IT WAS BETTER NOW; THE OVERALL CASE OUTCOME WAS IMPROVED. THE CONSUMER DISCONTINUED USING THE TOOTHBRUSH 4-5 DAYS AGO. NO FURTHER INFORMATION WAS PROVIDED. (B)(6) 2015 REPORTER RETURNED ORAL-B COMPLETE ACTION POWER TOOTHBRUSH AND 1 TOOTHBRUSH HEAD. PRODUCT INVESTIGATION IS IN PROGRESS. (B)(6) 2015 PRODUCT INVESTIGATION REVEALED CAUSE OF FAILURE TO BE EXCESSIVE WEAR DUE TO PROLONGED USE. NO MANUFACTURING OR DESIGN CAUSE IDENTIFIED.