BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COL TB CLASSIC/EXTRA CLEAN

    MDR report key: 16050389 · Received December 27, 2022

    Report

    Report Number
    3003205012-2022-00002
    Event Type
    Injury
    Date Received
    December 27, 2022
    Report Date
    December 2, 2022
    Manufacturer
    COLGATE SANXIAO CO., LTD.
    Product Code
    EFW
    Adverse Event
    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 CONSUMER (AGE AND GENDER UNKNOWN), WHO USED COL TB CLASSIC/EXTRA CLEAN AND TOOTHBRUSH BRISTLE CAME OFF AND LODGED IN THROAT AND HAD A PAINFUL EXPERIENCE. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. ON AN UNKNOWN DATE, CONSUMER STARTED USING COL TB CLASSIC/EXTRA CLEAN (FREQUENCY UNSPECIFIED). CONSUMER REPORTED THAT AFTER BRUSHING TEETH WITH COL TB CLASSIC/EXTRA CLEAN THE BRISTLE CAME OFF AND LODGED IN THROAT. THE CONSUMER HAD TO SPEND MOST OF DAY IN THE EMERGENCY ROOM AND ENT CLINIC. THE ENT DOCTOR WAS ABLE TO SCOPE AND REMOVE THE BRISTLE. THE CONSUMER DESCRIBED THE EXPERIENCE AS PAINFUL. ACTION TAKEN WITH COL TB CLASSIC/EXTRA CLEAN WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE EVENT BRISTLES LODGED IN THROAT WAS RESOLVED AND OUTCOME OF OTHER EVENTS WAS CONSIDERED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260551 COL TB CLASSIC/EXTRA CLEAN COL TB CLASSIC/EXTRA CLEAN EFW

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other