ORALBPWRORALCARERFLSKIDSEB10

Additional Manufacturer Narrative

PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.

Description of Event or Problem

BRUSH HEAD LODGED IN THROAT [FOREIGN BODY IN THROAT]. ALMOST CHOKED [CHOKING SENSATION]. BRUSH HEAD FELL OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: THIS IS A SERIOUS SPONTANEOUS REPORT RECEIVED ON 03-DEC-2025 FROM RELATIVE/FRIEND OF CONSUMER VIA LETTER. THIS CASE CONCERNS A 3.5-YEAR-OLD MALE CONSUMER. ON AN UNKNOWN DATE, THE CONSUMER BEGAN USING ORALBPWR ORALCARERFLS KIDS EB10 AND ORALBRCHG TOOTHBRUSH HANDLE. THE REPORTER STATED THAT ON AN UNKNOWN DATE, THE CONSUMER GOT ALMOST CHOKED (CHOKING SENSATION) AS THE BRUSH HEAD FELL OFF (DEVICE BREAKAGE) WHILE BRUSHING AND THE BRUSH HEAD BECAME LODGED IN CONSUMER¿S THROAT (FOREIGN BODY IN THROAT). NO RELEVANT MEDICAL HISTORY, HISTORICAL DRUG/PREV EXP, CONCURRENT CONDITIONS, CONCOMITANT PRODUCTS, OR MEDICATIONS WERE REPORTED. NO INFORMATION WAS PROVIDED REGARDING ANY VISIT TO A PHYSICIAN OR DENTIST IN RESPONSE TO THESE EVENTS. A TREATMENT WAS REPORTED, WHICH INVOLVED PULLING OUT OF THE BRUSH HEAD BY CONSUMER¿S PARENT. NO LABORATORY DATA WERE PROVIDED. THE ACTION TAKEN WITH THE SUSPECT PRODUCTS WERE UNKNOWN. THE OUTCOMES OF EVENTS WERE REPORTED AS RECOVERED FOR THE EVENTS OF FOREIGN BODY IN THROAT AND CHOKING SENSATION, AND NOT APPLICABLE FOR THE EVENT OF DEVICE BREAKAGE. THE CASE OUTCOME WAS REPORTED AS RECOVERED. SERIOUSNESS CRITERIA: INTERVENTION REQUIRED FOR THE EVENTS OF FOREIGN BODY IN THROAT AND CHOKING SENSATION. NO FURTHER INFORMATION IS AVAILABLE.