BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COL PTB 360 SONIC CHARCOAL

    MDR report key: 13477468 · Received February 8, 2022

    Report

    Report Number
    0002221095-2022-00005
    Event Type
    Injury
    Date Received
    February 8, 2022
    Report Date
    February 1, 2022
    Manufacturer
    COLGATE PALMOLIVE COMPANY
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS IS A SPONTANEOUS REPORT RECEIVED ON (B)(6) 2022 FROM A FEMALE CONSUMER (AGE UNKNOWN) WHO STATED THAT COL PTB 360 SONIC CHARCOAL TOOTHBRUSH HEAD CAME OFF IN HER MOUTH, THE OTHER PART WHICH WAS HELD IN THE HAND STABBED HER FACE AND HAD BIT OF SWELLING IN THE FACE. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. ON AN UNSPECIFIED DATE, WHILE THE CONSUMER WAS BRUSHING HER TEETH WITH A RECENTLY PURCHASED COL PTB 360 SONIC CHARCOAL TOOTHBRUSH, THE BRUSH HEAD CAME OFF IN HER MOUTH. CONSUMER REPORTED THE PART WHICH WAS HELD IN THE HAND STABBED HER FACE CLOSE TO HER EYE AND CAUSED A BIT OF SWELLING. ACTION TAKEN WITH COL PTB 360 SONIC CHARCOAL TOOTHBRUSH WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENTS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849627 COL PTB 360 SONIC CHARCOAL COL PTB 360 SONIC CHARCOAL JEQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other