ORALBPWRORALCARERFLS

Description of Event or Problem

SMASH/DAMAGE MY TOOTH [TOOTH INJURY]. PIN ON THE [ORAL-B REFILLS] BRUSH HEAD CAME OUT [DEVICE BREAKAGE]. CASE NARRATIVE: THIS IS A SERIOUS SPONTANEOUS REPORT RECEIVED ON (B)(6) 2025 FROM A NON-HEALTHCARE PROFESSIONAL (CONSUMER) VIA PHONE. THIS CASE CONCERNS A CONSUMER OF AN UNKNOWN AGE AND GENDER. THE CONSUMER'S MEDICAL HISTORY WERE NOT REPORTED. HISTORICAL DRUG/PREV EXP, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE CONSUMER STARTED USING ORALBPWRORALCARERFLS AND ORAL-B BRUSHHEADS, VERSION UNKNOWN FOR BRUSHING TEETH (DENTAL DISORDER PROPHYLAXIS). ON AN UNKNOWN DATE, THE PIN ON THE BRUSH HEAD CAME OUT (DEVICE BREAKAGE) AND SMASH/ DAMAGE THE TOOTH (TOOTH DAMAGE). NO LABORATORY DATA WAS PROVIDED. CORRECTIVE TREATMENT WERE NOT REPORTED. ACTION TAKEN WITH SUSPECT PRODUCT WAS UNKNOWN. CASE OUTCOME WAS REPORTED AS UNKNOWN. EVENT OUTCOME WAS REPORTED AS UNKNOWN FOR TOOTH DAMAGE AND NOT APPLICABLE FOR DEVICE BREAKAGE. SERIOUSNESS CRITERIA: OTHER (DAMAGE NATURAL TEETH) FOR EVENT TOOTH DAMAGE. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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