BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COL TB 360 LUMINOUS WHITE

    MDR report key: 7384883 · Received March 30, 2018

    Report

    Report Number
    3003205012-2018-00001
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    March 18, 2018
    Report Date
    March 20, 2018
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ARGUS DATABASE CASE ID ((B)(6) ) HAS BEEN CREATED FOR THIS REPORT.

    Description of Event or Problem · 1

    WE BOUGHT A PACK OF TOOTHBRUSHES ON SATURDAY AND WE USED THEM ON SUNDAY, BUT MY BOYFRIEND HAD A BRISTLE STUCK ON HIS TONSIL. HE HAD TO GO TO THE DOCTOR IN ORDER TO REMOVE THE BRISTLE [REMOVAL OF FOREIGN BODY FROM THROAT]. I NOTICED THAT ITS BRISTLES WERE FALLING OFF [DEVICE MALFUNCTION]. THIS IS A SPONTANEOUS REPORT RECEIVED FROM A CONSUMER'S GIRLFRIEND ON (B)(6) 2018, REGARDING HER BOYFRIEND WHO USED COLTB 360 LUMINOUS WHITE AND EXPERIENCED THE BRISTLES "FALLING OFF", ONE OF WHICH WAS STUCK IN HIS THROAT AND HE WENT TO THE DOCTOR AND THE OTOLARYNGOLOGIST REMOVED THE BRISTLES FROM HIS THROAT. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. ON (B)(6) 2018, CONSUMER STARTED USING COL TB 360 LUMINOUS WHITE FOR AN UNKNOWN INDICATION. CONSUMER'S GIRLFRIEND STATED THAT HER BOYFRIEND HAVE ALWAYS BOUGHT THE SAME TOOTHBRUSH. CONSUMER'S GIRLFRIEND REPORTED THAT SHE BOUGHT THE COL TB 360 LUMINOUS WHITE ON (B)(6) 018 (SATURDAY). ON (B)(6) 2018 (SUNDAY), HER BOYFRIEND USED THE COL TB 360 LUMINOUS WHITE TWICE AND HAD A SITUATION WITH ONE BRISTLE WHICH WAS STUCK IN HIS THROAT AND HE WENT TO SEE THE DOCTOR. THE OTOLARYNGOLOGIST REMOVED THE BRISTLES FROM HIS THROAT. CONSUMER'S GIRLFRIEND STATED THAT SHE NOTICED THAT THE TOOTHBRUSH BRISTLES WERE FALLING OFF. THE CONSUMER STOPPED USING COL TB 360 LUMINOUS WHITE ON (B)(6) 2018 (SUNDAY). CONSUMER'S GIRLFRIEND REPORTED THAT CONSUMER HAS A LITTLE BIT SENSITIVITY THAT REGION. AT THE TIME OF THIS REPORT, THE CONSUMER WAS RECOVERING FROM THE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228872 COL TB 360 LUMINOUS WHITE COL TB 360 LUMINOUS WHITE EFW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other