ORALBPWRBATTTOOTHBRUSHHANDLE4732

Additional Manufacturer Narrative

PRODUCT RETURN WAS REQUESTED BUT NOT RECEIVED SO FAR. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.

Description of Event or Problem

(BRUSH HEAD) LODGED ITSELF IN THROAT [FOREIGN BODY IN THROAT]. BRUSH HEAD DETACHED FROM THE HANDLE [DEVICE BREAKAGE]. A SPONTANEOUS REPORT WAS RECEIVED VIA E-MAIL ON 29-MAR-2021 FROM A CONSUMER OF UNKNOWN AGE AND GENDER STATING THAT THIS MORNING THEIR ORAL-B POWER ORAL CARE REFILLS CROSS ACTION POWER 3743 BRUSH SET DETACHED FROM THEIR ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE, VERSION UNKNOWN WHILE BRUSHING, AND IT LODGED ITSELF IN THEIR THROAT. THE BRUSH HEAD WAS SLICK WITH TOOTHPASTE AND THE CONSUMER WAS UNABLE TO GRASP IT TO PULL IT OUT, SO THEY HAD TO REPEATEDLY DO A SELF-HEIMLICH ON THE BACK OF A CHAIR TO DISLODGE IT. THE EVENT OUTCOME WAS RECOVERED. RELEVANT HISTORY: NONE REPORTED. THE CONSUMER HAS USED THIS PRODUCT BEFORE WITH UNKNOWN TOLERANCE. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

17-NOV-2021 PRODUCT INVESTIGATION RESULTS: SUSPECT IS HANDLE AND CONCOMITANT IS REFILL AFTER PRODUCT INVESTIGATION. PRODUCT RETURN WAS RECEIVED AND INVESTIGATED. PRODUCT INVESTIGATION RESULTS SHOWED THAT THE COMPLAINT IS CAUSED BY WEAR OF THE DRIVING SHAFT DUE TO USAGE OF ABRASIVE TOOTHPASTE IN COMBINATION WITH INSUFFICIENT CLEANING WITH USE OVER MANY YEARS.

Description of Event or Problem

(BRUSH HEAD) LODGED ITSELF IN THROAT [FOREIGN BODY IN THROAT]. BRUSH HEAD DETACHED FROM THE HANDLE [DEVICE BREAKAGE]. A SPONTANEOUS REPORT WAS RECEIVED VIA E-MAIL ON 29-MAR-2021 FROM A CONSUMER OF UNKNOWN AGE AND GENDER STATING THAT THIS MORNING THEIR ORAL-B POWER POWER ORAL CARE REFILLS CROSS ACTION POWER 3743 BRUSH SET DETACHED FROM THEIR ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE, VERSION UNKNOWN WHILE BRUSHING, AND IT LODGED ITSELF IN THEIR THROAT. THE BRUSH HEAD WAS SLICK WITH TOOTHPASTE AND THE CONSUMER WAS UNABLE TO GRASP IT TO PULL IT OUT, SO THEY HAD TO REPEATEDLY DO A SELF-HEIMLICH ON THE BACK OF A CHAIR TO DISLODGE IT. THE EVENT OUTCOME WAS RECOVERED. RELEVANT HISTORY: NONE REPORTED. THE CONSUMER HAS USED THIS PRODUCT BEFORE WITH UNKNOWN TOLERANCE. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. 23-APR-2021 FOLLOW UP VIA CONSUMER QUESTIONNAIRE: THE 59 YEAR OLD FEMALE CONSUMER REPORTED ON HER CONSUMER QUESTIONNAIRE THAT SHE USED ORAL-B POWER POWER ORAL CARE REFILLS CROSS ACTION POWER 3743 BRUSH SET WITH HER ORAL-B POWER RECHARGEABLE TOOTHBRUSH HANDLE, VERSION UNKNOWN TWICE A DAY. SHE STOPPED USING THE PRODUCT ON (B)(6) 2021. TREATMENT DETAILS: PHYSICIAN/DENTIST VISIT - NO; EMERGENCY ROOM VISIT - NO; SELF-HEIMLICH REPEATEDLY ON A CHAIR BACK. RELEVANT HISTORY: MEDICAL HISTORY: NONE (HAVE YOU HAD THE PROBLEM OR HAD A SIMILAR PROBLEM IN THE PAST? NO.), DRUG ALLERGY: PENICILLIN (PENICYLLIN). THE CONSUMER USED THIS PRODUCT BEFORE AND TOLERATED IT. THE CASE OUTCOME WAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. 27-OCT-2021 CASE UPDATE: CONCOMITANT PRODUCT UPDATED TO ORAL-B POWER BATTERY TOOTHBRUSH HANDLE 4732. NO FURTHER INFORMATION WAS PROVIDED. 17-NOV-2021 CASE UPDATE AND RECEIVED PRODUCT INVESTIGATION RESULTS: THE SUSPECT PRODUCT WAS UPDATED TO ORAL-B POWER BATTERY TOOTHBRUSH HANDLE 4732 AND THE CONCOMITANT PRODUCT WAS UPDATED TO ORAL-B POWER POWER ORAL CARE REFILLS CROSS ACTION POWER 3743 BRUSH SET. PRODUCT INVESTIGATION RESULTS FOR ORAL-B POWER BATTERY TOOTHBRUSH HANDLE 4732: THE ROOT CAUSE FOR EXTREME WEAR IS END OF LIFE OF HANDLE. BASED ON INVESTIGATION RESULTS, A MANUFACTURING OR DESIGN ISSUE CAN BE EXCLUDED. THE CONCLUSION CODE 'OTHER' WAS CHOSEN AS IT COVERS MULTIPLE CONCLUSION CODES: 'NO MANUFACTURING CAUSE' AND 'NO DESIGN ISSUE' IDENTIFIED BASED ON INVESTIGATION. MEASUREMENT NOT DONE, AS WEAR IS CLEARLY VISIBLE. NO FURTHER INFORMATION WAS PROVIDED.