ORALBRCHGTOOTHBRUSHHANDLE3776IOSRS5

Description of Event or Problem

TEETH ARE BROKEN [TOOTH FRACTURE], CHIPPED CROWN [COMPLICATION ASSOCIATED WITH DEVICE], BRUSH HEAD GREY PLASTIC PART CAME OFF IN MOUTH... BROKE - ORAL-B RECHARGEABLE TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED ON 14-JAN-2026 FROM A REPORTER (CONSUMER) VIA PHONE. THIS CASE CONCERNS A CONSUMER OF UNKNOWN AGE AND GENDER WHO STARTED USING ORALBRCHGTOOTHBRUSHHANDLE3776IOSRS5 AND ORALBPWRORALCARERFLSIOSRS ON AN UNKNOWN DATE FOR BRUSHING TEETH. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE THEIR TEETH BROKE (TOOTH FRACTURE), TOOTH CROWN CHIPPED (COMPLICATION ASSOCIATED WITH DEVICE) AS THE BRUSH HEAD BROKE WHILE BRUSHING TEETH AND GREY PLASTIC PART CAME OFF IN MOUTH (DEVICE BREAKAGE). THE CONSUMER HAD A MEDICAL HISTORY OF DENTAL CROWN AND TOOTH FILLING. NO CONCURRENT CONDITIONS, CONCOMITANT PRODUCT AND LABORATORY DATA WERE REPORTED. THE CONSUMER WENT TO DENTIST AND TOOTH WAS FILLED AGAIN WITH DENTAL FILLING. THE ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. THE OUTCOME WAS UNKNOWN FOR EVENT TOOTH FRACTURE, RECOVERED FOR DENTAL RESTORATION COMPLICATION AND NOT APPLICABLE FOR DEVICE BREAKAGE. SERIOUSNESS CRITERIA: OTHER (DAMAGE TO NATURAL TEETH) FOR THE EVENT TOOTH FRACTURE. NO FURTHER INFORMATION WAS AVAILABLE. ON 01-FEB-2026, SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED VIA PRODUCT INVESTIGATION REPORT. COMPLAINED PRODUCT WILL NOT BE AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. 10-MAR-2026, CASE (B)(4) WAS IDENTIFIED AS DUPLICATE FOR THE CASE (B)(4) TO DATA RECEIVED ON 14-JAN-2026 AND THE CASE INFORMATION FROM (B)(4) WAS MERGED IN (B)(4). ON 17-APR-2026, SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED FOLLOWING PRODUCT INVESTIGATION. THE BATCH/LOT. NO WAS CONFIRMED AS AP22530527. COMPLAINED PRODUCT WAS RETURNED TO MANUFACTURER ON 20-APR-2026. NO FURTHER INFORMATION WAS AVAILABLE.

Additional Manufacturer Narrative

COMPLAINED PRODUCT WILL NOT BE AVAILABLE. H3 OTHER TEXT: PENDING INVESTIGATION.

Additional Manufacturer Narrative

COMPLAINED PRODUCT WILL NOT BE AVAILABLE.

Description of Event or Problem

TEETH ARE BROKEN [TOOTH FRACTURE] , CHIPPED CROWN [COMPLICATION ASSOCIATED WITH DEVICE] , BRUSH HEAD GREY PLASTIC PART CAME OFF IN MOUTH... BROKE - ORAL-B RECHARGEABLE TOOTHBRUSH [DEVICE BREAKAGE] . CASE NARRATIVE: THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED ON 14-JAN-2026 FROM A REPORTER (CONSUMER) VIA PHONE. THIS CASE CONCERNS A CONSUMER OF UNKNOWN AGE AND GENDER WHO STARTED USING ORALBRCHGTOOTHBRUSHHANDLE3776IOSRS5 AND ORALBPWRORALCARERFLSIOSRS ON AN UNKNOWN DATE FOR BRUSHING TEETH. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE THEIR TEETH BROKE (TOOTH FRACTURE), TOOTH CROWN CHIPPED (COMPLICATION ASSOCIATED WITH DEVICE) AS THE BRUSH HEAD BROKE WHILE BRUSHING TEETH AND GREY PLASTIC PART CAME OFF IN MOUTH (DEVICE BREAKAGE). THE CONSUMER HAD A MEDICAL HISTORY OF DENTAL CROWN AND TOOTH FILLING. NO CONCURRENT CONDITIONS, CONCOMITANT PRODUCT AND LABORATORY DATA WERE REPORTED. THE CONSUMER WENT TO DENTIST AND TOOTH WAS FILLED AGAIN WITH DENTAL FILLING. THE ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. THE OUTCOME WAS UNKNOWN FOR EVENT TOOTH FRACTURE, RECOVERED FOR DENTAL RESTORATION COMPLICATION AND NOT APPLICABLE FOR DEVICE BREAKAGE. SERIOUSNESS CRITERIA: OTHER (DAMAGE TO NATURAL TEETH) FOR THE EVENT TOOTH FRACTURE. NO FURTHER INFORMATION WAS AVAILABLE. ON 01-FEB-2026, SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED VIA PRODUCT INVESTIGATION REPORT. COMPLAINED PRODUCT WILL NOT BE AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE.

Additional Manufacturer Narrative

COMPLAINED PRODUCT WILL NOT BE AVAILABLE.

Description of Event or Problem

TEETH ARE BROKEN [TOOTH FRACTURE] . CHIPPED CROWN [COMPLICATION ASSOCIATED WITH DEVICE] . BRUSH HEAD GREY PLASTIC PART CAME OFF IN MOUTH... BROKE - ORAL-B RECHARGEABLE TOOTHBRUSH [DEVICE BREAKAGE]. CASE NARRATIVE: THIS SERIOUS SPONTANEOUS REPORT WAS RECEIVED ON 14-JAN-2026 FROM A REPORTER (CONSUMER) VIA PHONE. THIS CASE CONCERNS A CONSUMER OF UNKNOWN AGE AND GENDER WHO STARTED USING ORALBRCHGTOOTHBRUSHHANDLE3776IOSRS5 AND ORALBPWRORALCARERFLSIOSRS ON AN UNKNOWN DATE FOR BRUSHING TEETH. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE THEIR TEETH BROKE (TOOTH FRACTURE), TOOTH CROWN CHIPPED (COMPLICATION ASSOCIATED WITH DEVICE) AS THE BRUSH HEAD BROKE WHILE BRUSHING TEETH AND GREY PLASTIC PART CAME OFF IN MOUTH (DEVICE BREAKAGE). THE CONSUMER HAD A MEDICAL HISTORY OF DENTAL CROWN AND TOOTH FILLING. NO CONCURRENT CONDITIONS, CONCOMITANT PRODUCT AND LABORATORY DATA WERE REPORTED. THE CONSUMER WENT TO DENTIST AND TOOTH WAS FILLED AGAIN WITH DENTAL FILLING. THE ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. THE OUTCOME WAS UNKNOWN FOR EVENT TOOTH FRACTURE, RECOVERED FOR DENTAL RESTORATION COMPLICATION AND NOT APPLICABLE FOR DEVICE BREAKAGE. SERIOUSNESS CRITERIA: OTHER (DAMAGE TO NATURAL TEETH) FOR THE EVENT TOOTH FRACTURE. NO FURTHER INFORMATION WAS AVAILABLE. ON 01-FEB-2026, SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED VIA PRODUCT INVESTIGATION REPORT. COMPLAINED PRODUCT WILL NOT BE AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. 10-MAR-2026, CASE (B)(4) WAS IDENTIFIED AS DUPLICATE FOR THE CASE (B)(4) TO DATA RECEIVED ON 14-JAN-2026 AND THE CASE INFORMATION FROM (B)(4) WAS MERGED IN (B)(4).