ORALBPWRORALCARERFLSKIDSEB10

Description of Event or Problem

HEAD WITH BRISTLES FELL OFF AND GOT STUCK IN ESOPHAGUS [FOREIGN BODY IN THROAT]. ORAL-B KIDS AUTOBRUSH BROKE...HEAD WITH BRISTLES FELL OFF [DEVICE BREAKAGE]. CASE NARRATIVE: A PARENT REPORTED SPONTANEOUSLY VIA E-MAIL ON (B)(6)2024 STATING THAT THEIR SON (MALE OF UNSPECIFIED AGE) USED ORAL-B POWER ORAL CARE REFILLS KIDS EB10 (BEGINNING ON AN UNSPECIFIED DATE) AND IT BROKE WHILE HE WAS BRUSHING HIS TEETH. THE HEAD WITH BRISTLES FELL OFF AND GOT STUCK IN THEIR SON'S ESOPHAGUS (ON AN UNSPECIFIED DATE). THE PARENT WAS ABLE TO USE THE HEIMLICH MANEUVER. CONTINUED USE OF THE DEVICE WAS NOT SPECIFIED AND ADDITIONAL DEVICE USAGE INFORMATION WAS NOT SPECIFIED. THE ADVERSE EVENT OUTCOME WAS UNKNOWN. RELEVANT HISTORY: NONE REPORTED. EXACT DEVICE USED PREVIOUSLY: UNKNOWN. CONCOMITANT PRODUCT(S): ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. THE CASE OUTCOME WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. 21-NOV-2024 FOLLOW UP VIA WEBLINK: THE SUSPECT PRODUCT LOT WAS 1057B211C0. THE ADVERSE EVENT OUTCOME REMAINED UNKNOWN. THE CASE OUTCOME REMAINED UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.