BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COL TB CLASSIC/EXTRA CLEAN

    MDR report key: 13825187 · Received March 19, 2022

    Report

    Report Number
    3003205012-2022-00007
    Event Type
    Injury
    Date Received
    March 19, 2022
    Report Date
    March 7, 2022
    Manufacturer
    COLGATE PALMOLIVE COMPANY
    Product Code
    EFW
    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 07-MAR-2022 FROM A CONSUMER REGARDING AN (B)(6)SON WHO USED COL TB CLASSIC/EXTRA CLEAN AND WAS SCREAMING IN PAIN AND A LONG WHITE BRISTLE LODGED IN HIS TONSIL. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. SEVERAL WEEKS AGO, THE REPORTER PURCHASED A PACK OF COL TB CLASSIC/EXTRA CLEAN. ON AN UNSPECIFIED DATE, THE CONSUMER'S SON WAS USING ONE OF THE NEW COL TB CLASSIC/EXTRA CLEAN TOOTHBRUSH AND STARTED SCREAMING IN PAIN AND POINTING TO HIS THROAT. THE REPORTER WAS ABLE TO SEE A LONG WHITE BRISTLE LODGED IN THE CHILD'S TONSIL. THE REPORTER WAS NOT ABLE TO REMOVE THE BRISTLE AND TOOK THE CHILD TO THE EMERGENCY ROOM. A SURGEON WAS ABLE TO REMOVE THE BRISTLE AFTER SEVERAL ATTEMPTS. THE REPORTER INSPECTED THE BRUSH AFTER RETURNING HOME AND NOTICED A BROKEN OFF BRISTLE STICKING OUT FROM THE TOOTHBRUSH. IT WAS REPORTED THE CHILD WAS AFRAID AND CONCERNED TO BRUSH HIS TEETH AFTER THE TRAUMATIC EVENT. ACTION TAKEN WITH COL TB CLASSIC/EXTRA CLEAN WAS UNKNOWN. AT THE TIME OF THIS REPORT, OUTCOME OF THE EVENTS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531020 COL TB CLASSIC/EXTRA CLEAN COL TB CLASSIC/EXTRA CLEAN EFW COLGATE PALMOLIVE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Other