ORALBPWRORALCARERFLSPRECISIONCLEANEB20RXBRUSHSET4CT

Additional Manufacturer Narrative

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

Description of Event or Problem

CHOKING [CHOKING] BRUSH PART DETACH RESULTING IT DOWN MY THROAT [FOREIGN BODY IN THROAT] BRUSH PART DETACH/SMALL METAL PIN UNDER MY TONGUE - ORAL-B REFILLS [DEVICE BREAKAGE] CASE NARRATIVE: THIS IS A SERIOUS SPONTANEOUS REPORT RECEIVED ON 09-NOV-2025 FROM CONSUMER VIA SOCIAL MEDIA. THIS CASE INVOLVES A MALE CONSUMER OF UNKNOWN AGE. ON AN UNKNOWN DATE IN NOVEMBER 2025, THE CONSUMER BEGAN USING ORALBPWRORALCARERFLSPRECISIONCLEANEB20RXBRUSHSET4CT AND ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE IN NOVEMBER 2025, THE BRUSH PART DETACHED FROM THE HEAD ARM AND FOUND A SMALL METAL PIN UNDER HIS TONGUE (DEVICE BREAKAGE). AS THE BRUSH PART DETACHED, IT WENT DOWN THE CONSUMER¿S THROAT (FOREIGN BODY IN THE THROAT), RESULTING IN CHOKING. 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 THE PARTNER QUICKLY HITTING THE CONSUMER¿S BACK, AFTER WHICH THE CONSUMER COUGHED IT UP, AND THEN FOUND A SMALL METAL PIN UNDER THE TONGUE. NO LABORATORY DATA WERE PROVIDED. THE ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. EVENT OUTCOMES WERE REPORTED AS RECOVERED FOR THE EVENTS OF CHOKING AND FOREIGN BODY IN THROAT, AND NOT APPLICABLE FOR DEVICE BREAKAGE. THE CASE OUTCOME WAS REPORTED AS RECOVERED. SERIOUSNESS CRITERIA: OTHER (SERIOUS ILLNESS / INJURY AND DETERIORATION OF HEALTH) FOR THE EVENTS OF CHOKING AND FOREIGN BODY IN THROAT. NO FURTHER INFORMATION IS AVAILABLE.

Description of Event or Problem

CHOKING, BRUSH PART DETACH RESULTING IT DOWN MY THROAT [FOREIGN BODY IN THROAT], BRUSH PART DETACH/SMALL METAL PIN UNDER MY TONGUE - ORAL-B REFILLS [DEVICE BREAKAGE], PRODUCT COUNTERFEIT - ORAL-B REFILLS [PRODUCT COUNTERFEIT]. CASE NARRATIVE: THIS IS A SERIOUS SPONTANEOUS REPORT RECEIVED ON 09-NOV-2025 FROM CONSUMER VIA SOCIAL MEDIA. THIS CASE INVOLVES A MALE CONSUMER OF UNKNOWN AGE. ON AN UNKNOWN DATE IN (B)(6) 2025, THE CONSUMER BEGAN USING ORALBPWRORALCARERFLSPRECISIONCLEANEB20RXBRUSHSET4CT AND ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2025, THE BRUSH PART DETACHED FROM THE HEAD ARM AND FOUND A SMALL METAL PIN UNDER HIS TONGUE (DEVICE BREAKAGE). AS THE BRUSH PART DETACHED, IT WENT DOWN THE CONSUMER¿S THROAT (FOREIGN BODY IN THE THROAT), RESULTING IN CHOKING. 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 THE PARTNER QUICKLY HITTING THE CONSUMER¿S BACK, AFTER WHICH THE CONSUMER COUGHED IT UP, AND THEN FOUND A SMALL METAL PIN UNDER THE TONGUE. NO LABORATORY DATA WERE PROVIDED. THE ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. EVENT OUTCOMES WERE REPORTED AS RECOVERED FOR THE EVENTS OF CHOKING AND FOREIGN BODY IN THROAT, AND NOT APPLICABLE FOR DEVICE BREAKAGE. THE CASE OUTCOME WAS REPORTED AS RECOVERED. SERIOUSNESS CRITERIA: OTHER (SERIOUS ILLNESS / INJURY AND DETERIORATION OF HEALTH) FOR THE EVENTS OF CHOKING AND FOREIGN BODY IN THROAT. NO FURTHER INFORMATION IS AVAILABLE. SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED ON 05-DEC-2025, WHICH INCLUDED AN UPDATE TO THE BATCH/LOT NUMBER FOR THE SUSPECT PRODUCT. THE CASE REMAINS ASSESSED AS SERIOUS BASED ON THE SERIOUSNESS CRITERIA: OTHER (SERIOUS ILLNESS / INJURY AND DETERIORATION OF HEALTH) FOR THE EVENTS OF CHOKING AND FOREIGN BODY IN THROAT. NO FURTHER INFORMATION IS AVAILABLE. ON 11-FEB-2026, SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED VIA PRODUCT INVESTIGATION REPORT. THE PRODUCT INVOLVED WAS CONFIRMED TO BE A COUNTERFEIT, SO THE PRODUCT PROBLEM WILL BE REMOVED FROM THE (ORALBPWRORALCARERFLSPRECISIONCLEANEB20RXBRUSHSET4CT). NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

11-FEB-2026: PRODUCT RETURN WAS RECEIVED AND IDENTIFIED AS A NON-GENUINE ORAL-B PRODUCT, IT WAS NOT MANUFACTURED UNDER P&G CONTROL.

Description of Event or Problem

CHOKING [CHOKING] BRUSH PART DETACH RESULTING IT DOWN MY THROAT [FOREIGN BODY IN THROAT] BRUSH PART DETACH/SMALL METAL PIN UNDER MY TONGUE - ORAL-B REFILLS [DEVICE BREAKAGE]. CASE NARRATIVE: THIS IS A SERIOUS SPONTANEOUS REPORT RECEIVED ON 09-NOV-2025 FROM CONSUMER VIA SOCIAL MEDIA. THIS CASE INVOLVES A MALE CONSUMER OF UNKNOWN AGE. ON AN UNKNOWN DATE IN NOVEMBER 2025, THE CONSUMER BEGAN USING ORAL BPWR ORAL CARERFLSPRECISIONCLEANEB20RXBRUSHSET4CT AND ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE IN NOVEMBER 2025, THE BRUSH PART DETACHED FROM THE HEAD ARM AND FOUND A SMALL METAL PIN UNDER HIS TONGUE (DEVICE BREAKAGE). AS THE BRUSH PART DETACHED, IT WENT DOWN THE CONSUMER¿S THROAT (FOREIGN BODY IN THE THROAT), RESULTING IN CHOKING. 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 THE PARTNER QUICKLY HITTING THE CONSUMER¿S BACK, AFTER WHICH THE CONSUMER COUGHED IT UP, AND THEN FOUND A SMALL METAL PIN UNDER THE TONGUE. NO LABORATORY DATA WERE PROVIDED. THE ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. EVENT OUTCOMES WERE REPORTED AS RECOVERED FOR THE EVENTS OF CHOKING AND FOREIGN BODY IN THROAT, AND NOT APPLICABLE FOR DEVICE BREAKAGE. THE CASE OUTCOME WAS REPORTED AS RECOVERED. SERIOUSNESS CRITERIA: OTHER (SERIOUS ILLNESS / INJURY AND DETERIORATION OF HEALTH) FOR THE EVENTS OF CHOKING AND FOREIGN BODY IN THROAT. NO FURTHER INFORMATION IS AVAILABLE. SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED ON 05-DEC-2025, WHICH INCLUDED AN UPDATE TO THE BATCH/LOT NUMBER FOR THE SUSPECT PRODUCT. THE CASE REMAINS ASSESSED AS SERIOUS BASED ON THE SERIOUSNESS CRITERIA: OTHER (SERIOUS ILLNESS / INJURY AND DETERIORATION OF HEALTH) FOR THE EVENTS OF CHOKING AND FOREIGN BODY IN THROAT. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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