ORALBPWRORALCARERFLS3DWHITEEB18

Additional Manufacturer Narrative

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

Description of Event or Problem

IRREGULAR ANTERIOR MARGIN OF THE RIGHT NASAL BONE... NASAL BONE FRACTURE "[CRANIOFACIAL FRACTURE]", DEVIATED NASAL SEPTUM "[NASAL SEPTUM DEVIATION]", NOSE BLEED "[EPISTAXIS]", NASAL MUCOSAL SWELLING "[NASAL CONGESTION]", PIERCED RIGHT NASAL CAVITY...NASAL STAB WOUND "[NASAL INJURY]", NOSE PAIN "[RHINALGIA]", BRUSH HEAD SEPARATED/DETACHED FROM THE HANDLE-ORAL-B TOOTHBRUSH "[DEVICE BREAKAGE]". CASE NARRATIVE: THIS SERIOUS SPONTANEOUS CASE WAS RECEIVED ON 04-JUN-2026 FROM A REPORTER (RELATIVE/FRIEND AND CONSUMER) AND STORE VIA PHONE. THIS CASE CONCERNS A FEMALE CONSUMER OF UNKNOWN AGE WHO STARTED USING ORALBPWRORALCARERFLS3DWHITEEB18 ON (B)(6) 2026 AND ORALBRCHGTOOTHBRUSHHANDLE ON AN UNKNOWN DATE FOR BRUSHING TEETH. THE CONSUMER REPORTED THAT ON (B)(6) 2026, THE TOOTHBRUSH HEAD SUDDENLY DETACHED FROM THE HANDLE (DEVICE BREAKAGE), THE TOOTHBRUSH HEAD CAUSED THE TECHNICAL SHAFT INSIDE THE ELECTRIC TOOTHBRUSH TO ROTATE AT HIGH SPEED AND PIERCED HER RIGHT NASAL CAVITY (NASAL INJURY) CAUSING A LARGE AMOUNT OF BLEEDING FROM HER NOSE (EPISTAXIS). ON THE SAME DAY, SHE STOPPED THE BLEEDING. ON (B)(6) 2026, DUE TO NOSE PAIN (RHINALGIA), SHE HAD AN EMERGENCY VISIT AT THE HOSPITAL WHERE A MEDICAL PROCEDURE WAS PERFORMED AS TREATMENT AFTER CT SCAN WAS DONE. UPON FOLLOW-UP CONSULTATION ON (B)(6) 2026, THE DOCTOR DIAGNOSED A NASAL BONE FRACTURE (CRANIOFACIAL FRACTURE) AND NASAL MUCOSAL SWELLING (NASAL CONGESTION). NO RELEVANT MEDICAL HISTORY AND CONCURRENT CONDITIONS WERE REPORTED. ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. OUTCOME OF THE EVENT CRANIOFACIAL FRACTURE, NASAL CONGESTION, RHINALGIA AND NASAL INJURY WAS UNKNOWN, RECOVERED FOR EPISTAXIS AND NOT APPLICABLE FOR DEVICE BREAKAGE. THE CASE OUTCOME WAS IMPROVED. THE CASE WAS ASSESSED AS SERIOUS WITH SERIOUSNESS CRITERIA: OTHER (SERIOUS ILLNESS, INJURY, DETERIORATION OF HEALTH) FOR THE EVENT OF CRANIOFACIAL FRACTURE. NO FURTHER INFORMATION WAS AVAILABLE. ON 09-JUN-2026, ADDITIONAL INFORMATION WAS RECEIVED VIA CHAT. THE CONSUMER REPORTED THAT THE CT SCAN REPORTS INDICATED IRREGULAR ANTERIOR MARGIN OF THE RIGHT NASAL BONE, POSSIBLE MICROFRACTURE AND DEVIATED NASAL SEPTUM (NASAL SEPTUM DEVIATION) ON AN UNKNOWN DATE IN 2026. SHE ALSO MENTIONED ABOUT A NASAL STAB WOUND. THE OUTCOME OF THE EVENT NASAL SEPTUM DEVIATION WAS UNKNOWN. THE CASE OUTCOME REMAINED IMPROVED. THE CASE WAS ASSESSED AS SERIOUS WITH SERIOUSNESS CRITERIA: OTHER (SERIOUS ILLNESS, INJURY, DETERIORATION OF HEALTH) FOR THE EVENT OF NASAL SEPTUM DEVIATION. NO FURTHER INFORMATION WAS AVAILABLE. ON 11-JUN-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.