BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORALKLEEN

    MDR report key: 16462812 · Received March 1, 2023

    Report

    Report Number
    3018418236-2023-00001
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    December 28, 2022
    Report Date
    March 1, 2023
    Manufacturer
    ORALKLEEN LLC
    Product Code
    JEQ
    UDI-DI
    00850030081001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN EXPERIENCED ICU NURSE HAD JUST STARTED TO BRUSH A COOPERATIVE PATIENT'S TEETH USING ONE OF THE PREPACKAGED REPLACEMENT TOOTHBRUSH HEADS. SHE SAID THE PATIENT BARELY BIT DOWN AND THE BRUSH HEAD POPPED OFF. IT LANDED ON HIS TONGUE AND SHE QUICKLY STUCK HER FINGERS INSIDE HIS MOUTH TO FISH IT OUT AND SAVE IT. THE FAILED PARTS WERE GATHERED AND RETURNED TO A COMPANY REPRESENTATIVE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201667 ORALKLEEN POWERED TOOTHBRUSH JEQ ORALKLEEN LLC V1 0422 00850030081001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R