BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COL TB 360 OPTIC WHITE

    MDR report key: 7411277 · Received April 10, 2018

    Report

    Report Number
    3003205012-2018-00002
    Event Type
    Injury
    Date Received
    April 10, 2018
    Report Date
    March 28, 2018
    Product Code
    EFW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ARGUS DATABASE CASE ID (B)(4) HAS BEEN CREATED FOR THIS REPORT.

    Description of Event or Problem · 1

    THE BRISTLES WERE LOOSE. ONE CAME OFF AND LODGED INTO MY TONSILS, AND I HAD TO GO TO URGENT CARE TO GET IT REMOVED [REMOVAL OF FOREIGN BODY FROM THROAT]. THE BRISTLES WERE LOOSE. ONE CAME OFF AND LODGED INTO MY TONSILS, AND I HAD TO GO TO URGENT CARE TO GET IT REMOVED [DEVICE MALFUNCTION]. THIS IS A SPONTANEOUS REPORT RECEIVED FROM AN ADULT MALE CONSUMER (AGE UNSPECIFIED) ON (B)(6) 2018, WHO USED COL TB 360 OPTIC WHITE AND AS THE BRISTLES WERE LOOSE, ONE BRISTLE CAME OFF AND LODGED INTO HIS TONSILS, AND HE WENT TO THE URGENT CARE AND GOT IT REMOVED MEDICALLY FROM HIS TONSILS. THERE WAS NO RELEVANT MEDICAL HISTORY PROVIDED. ON AN UNSPECIFIED DATE CONSUMER STARTED USING COL TB 360 OPTIC WHITE. THE CONSUMER REPORTED THAT THE BRISTLES OF COL TB 360 OPTIC WHITE WERE LOOSE AND ONE BRISTLE CAME OFF AND LODGED INTO HIS TONSILS AND HE WENT TO THE URGENT CARE AND GOT IT REMOVED MEDICALLY FROM HIS TONSILS (DETAILS NOT PROVIDED). ACTION TAKEN WITH COL TB 360 OPTIC WHITE WAS UNKNOWN. AT THE TIME OF THIS REPORT, OUTCOME OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255025 COL TB 360 OPTIC WHITE COL TB 360 OPTIC WHITE EFW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other