ORALBPWRBATTTOOTHBRUSHHANDLECROSSACTNPWR4732

Additional Manufacturer Narrative

RETURN OF PRODUCT HAS BEEN REQUESTED. PRODUCT AND LOT NUMBER NOT PROVIDED BY THE REPORTER, THEREFORE UNABLE TO PROCEED WITH PRODUCT INVESTIGATION AT THIS TIME. FULL EVALUATION WILL OCCUR UPON RECEIPT OF THE RETURNED PRODUCT.

Description of Event or Problem

TORE UP ROOF OF MOUTH [MOUTH INJURY], PAIN IN THE ROOF OF THE MOUTH [ORAL PAIN], THROAT IRRITATED [THROAT IRRITATION], BRUSHHEAD LODGED IN THROAT SIDEWAYS [FOREIGN BODY IN RESPIRATORY TRACT], MEDAL PRONG ON HANDLE TORE UP MOUTH - ORAL-B HANDLE [INJURY ASSOCIATED WITH DEVICE], BRUSHHEAD CAME OFF [DEVICE BREAKAGE]. CASE DESCRIPTION: REPORT SOURCE: SPONTANEOUS. A (B)(6) FEMALE CONSUMER REPORTED VIA PHONE ON (B)(6) 2018 THAT WHILE BRUSHING HER TEETH TWO WEEKS AGO IN THE SHOWER WITH AN ORAL-B POWER TOOTHBRUSH, VERSION UNKNOWN, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN CAME OFF AND LODGED SIDEWAYS IN HER THROAT. SHE REPORTED THE METAL PRONG OF THE TOOTHBRUSH HOLDER WAS STILL TURNING ON THE ROOF OF HER MOUTH AND TORE UP THE ROOF OF HER MOUTH, AND IT WAS STILL HURTING TODAY. SHE VISITED A DOCTOR WHO TOLD HER IT WOULD TAKE TIME TO HEAL. THE CONSUMER HAD USED THE PRODUCT FOR ONE MONTH, AND DISCONTINUED USE OF THE PRODUCT TWO WEEKS AGO. THE CASE OUTCOME WAS IMPROVED. ALLERGY/INTOLERANCE: NONE. CONCOMITANT PRODUCT(S): COLGATE TOOTHPASTE. NO FURTHER INFORMATION WAS PROVIDED. ON 16-MAR-2018 RECEIVED CONSUMER'S FOLLOW-UP E-MAIL: THE CONSUMER REPORTED THAT HER THROAT WAS STILL IRRITATED BUT HOPEFULLY WOULD BE FINE SOON. THE CASE OUTCOME REMAINED IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

02-JUL-2018 PRODUCT INVESTIGATION RESULTS: REPORTER RETURNED PRODUCT ON 21-MAY-2018. THE PRODUCT WAS IDENTIFIED AS AN ORAL-B POWER BATTERY TOOTHBRUSH HANDLE CROSS ACTION POWER 4732 ON 12-JUN-2018. PRODUCT RETURN WAS RECEIVED AND INVESTIGATED. INVESTIGATION RESULTS SHOWED THAT COMPLAINT WAS CAUSED BY A BREAKAGE DUE TO AN EFFECT OF FORCE BECAUSE OF CONSUMER HANDLING.

Description of Event or Problem

TORE UP ROOF OF MOUTH [MOUTH INJURY] PAIN IN THE ROOF OF THE MOUTH [ORAL PAIN] THROAT IRRITATED [THROAT IRRITATION] BRUSHHEAD LODGED IN THROAT SIDEWAYS [FOREIGN BODY IN RESPIRATORY TRACT] MEDAL PRONG ON HANDLE TORE UP MOUTH - ORAL-B HANDLE [INJURY ASSOCIATED WITH DEVICE] BRUSHHEAD CAME OFF [DEVICE BREAKAGE] CASE DESCRIPTION: REPORT SOURCE: SPONTANEOUS. A 55 YEAR OLD FEMALE CONSUMER REPORTED VIA PHONE ON (B)(6)-2018 THAT WHILE BRUSHING HER TEETH TWO WEEKS AGO IN THE SHOWER WITH AN ORAL-B POWER TOOTHBRUSH, VERSION UNKNOWN, THE ORAL-B BRUSHHEAD, VERSION UNKNOWN CAME OFF AND LODGED SIDEWAYS IN HER THROAT. SHE REPORTED THE METAL PRONG OF THE TOOTHBRUSH HOLDER WAS STILL TURNING ON THE ROOF OF HER MOUTH AND TORE UP THE ROOF OF HER MOUTH, AND IT WAS STILL HURTING TODAY. SHE VISITED A DOCTOR WHO TOLD HER IT WOULD TAKE TIME TO HEAL. THE CONSUMER HAD USED THE PRODUCT FOR ONE MONTH, AND DISCONTINUED USE OF THE PRODUCT TWO WEEKS AGO.THE CASE OUTCOME WAS IMPROVED. ALLERGY/INTOLERANCE: NONE. CONCOMITANT PRODUCT(S): COLGATE TOOTHPASTE. NO FURTHER INFORMATION WAS PROVIDED. 16-MAR-2018 RECEIVED CONSUMER'S FOLLOW-UP E-MAIL: THE CONSUMER REPORTED THAT HER THROAT WAS STILL IRRITATED BUT HOPEFULLY WOULD BE FINE SOON. THE CASE OUTCOME REMAINED IMPROVED. NO FURTHER INFORMATION WAS PROVIDED.