BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A AND H SPINBRUSH PRO CLEAN UNSPECIFIED

    MDR report key: 16361894 · Received February 13, 2023

    Report

    Report Number
    2280705-2023-00248
    Event Type
    Injury
    Date Received
    February 13, 2023
    Report Date
    February 2, 2023
    Manufacturer
    CHURCH & DWIGHT CO., INC
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT (2023-CDW-00248, 007702306A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A MALE CONSUMER (AGE UNSPECIFIED) WHOSE HEAD OF THE TOOTHBRUSH CAME OFF AND TOOTH SHIFTED AND CHIPPED WHILE USING A AND H SPINBRUSH PRO CLEAN UNSPECIFIED. THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER INITIATED A AND H SPINBRUSH PRO CLEAN UNSPECIFIED VIA THE DENTAL ROUTE. THE HEAD OF THE TOOTHBRUSH CAME OFF, AND HIS TOOTH SHIFTED AND CHIPPED. LATER, HE HAD NEW INVISALIGN TRAYS FOR HIS SHIFTED TOOTH. THE ACTION TAKEN WITH THE A AND H SPINBRUSH PRO CLEAN UNSPECIFIED IS UNKNOWN. THE OUTCOME OF THE EVENTS, TOOTH SHIFTED AND CHIPPED IS UNKNOWN. THE OUTCOME OF THE EVENT THE HEAD OF THE TOOTHBRUSH CAME OFF IS NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721965 A AND H SPINBRUSH PRO CLEAN UNSPECIFIED TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention