ORALBPWRORALCARERFLSIOSRS

Additional Manufacturer Narrative

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

Description of Event or Problem

TEETH BROKEN [TOOTH FRACTURE]. CHIPPED CROWN [COMPLICATION ASSOCIATED WITH DEVICE] . [ORAL-B] BRUSH HEAD BROKE... GREY PLASTIC PART CAME OFF IN MOUTH [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 ORALBPWRORALCARERFLSIOSRS (BATCH/LOT NUMBER AP22530527) AND ORALBRCHGTOOTHBRUSHHANDLE3776IOSRS5 ON AN UNKNOWN DATE FOR BRUSHING TEETH. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE THEIR TEETH BROKE (TOOTH FRACTURE), TOOTH CROWN CHIPPED (DENTAL RESTORATION COMPLICATION) 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 16-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED VIA PRODUCT INVESTIGATION REPORT. INSUFFICIENT INFORMATION FOR INVESTIGATION. PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT AND EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN. NO FURTHER INFORMATION WAS AVAILABLE. 10-MAR-2026, CASE (B)(4) WILL BE DELETED FROM P&G DATABASE AS IT IS DUPLICATE CASE OF (B)(4) TO DATA RECEIVED ON 14-JAN-2026.

Description of Event or Problem

TEETH BROKEN [TOOTH FRACTURE]. CHIPPED CROWN [COMPLICATION ASSOCIATED WITH DEVICE]. [ORAL-B] BRUSH HEAD BROKE... GREY PLASTIC PART CAME OFF IN MOUTH [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 ORALBPWRORALCARERFLSIOSRS (BATCH/LOT NUMBER AP22530527) AND ORALBRCHGTOOTHBRUSHHANDLE3776IOSRS5 ON AN UNKNOWN DATE FOR BRUSHING TEETH. THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE THEIR TEETH BROKE (TOOTH FRACTURE), TOOTH CROWN CHIPPED (DENTAL RESTORATION COMPLICATION) 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 16-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED VIA PRODUCT INVESTIGATION REPORT. INSUFFICIENT INFORMATION FOR INVESTIGATION. PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT AND EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN. NO FURTHER INFORMATION WAS AVAILABLE

Additional Manufacturer Narrative

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