BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINBRUSH PRO CLEAN SOFT

    MDR report key: 20265268 · Received September 20, 2024

    Report

    Report Number
    2280705-2024-01453
    Event Type
    Injury
    Date Received
    September 20, 2024
    Report Date
    September 20, 2024
    Manufacturer
    CHURCH & DWIGHT CO.,
    Product Code
    JEQ
    Removal / Correction Number
    NOT AVAIL.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOT AVAIL..

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT (2024-CDW-01453,(B)(6) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A FEMALE CONSUMER (AGE UNSPECIFIED) WHO EXPERIENCED THE SPINBRUSH PRO CLEAN SOFT WAS SO AGGRESSIVE THAT IT BROKE AND SHATTERED THE SIDE OF HER TOOTH WHILE USING. ON AN UNSPECIFIED DATE, THE CONSUMER INITIATED SPINBRUSH PRO CLEAN SOFT VIA THE DENTAL ROUTE. WHILE USING THE BRUSH, SHE EXPERIENCED IT WAS SO AGGRESSIVE THAT IT WAS HITTING AGAINST THE BACK TEETH, AND IT BROKE AND SHATTERED THE SIDE OF HER TOOTH. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH SPINBRUSH PRO CLEAN SOFT WAS UNKNOWN. THE OUTCOME OF THE EVENT IT BROKE AND SHATTERED THE SIDE OF THE TOOTH WAS UNKNOWN. THE OUTCOME OF THE EVENT SO AGGRESSIVE WAS NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331887 SPINBRUSH PRO CLEAN SOFT TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., NOT AVAIL. NOT AVAIL.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other