BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A AND H SPINBRUSH PRO WHITENING MEDIUM

    MDR report key: 15299836 · Received August 26, 2022

    Report

    Report Number
    2280705-2022-01275
    Event Type
    Injury
    Date Received
    August 26, 2022
    Report Date
    August 12, 2022
    Manufacturer
    CHURCH & DWIGHT CO., INC
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT (2022-CDW-01275, 007598719A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A FEMALE CONSUMER (AGE UNSPECIFIED) WHO EXPERIENCED A CHIPPED TOOTH COINCIDENT WITH A AND H SPINBRUSH PRO WHITENING (A AND H SPINBRUSH PRO WHITENING MEDIUM). THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER INITIATED A AND H SPINBRUSH PRO WHITENING (A AND H SPINBRUSH PRO WHITENING MEDIUM) VIA THE DENTAL ROUTE. AT THE FIRST TIME OF USE, IT CHIPPED A TOOTH. SHE STATED THAT THE PRODUCT WAS TERRIBLE AND EXTREMELY HARD ON HER TEETH. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH A AND H SPINBRUSH PRO WHITENING (A AND H SPINBRUSH PRO WHITENING MEDIUM) AND THE OUTCOME OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436133 A AND H SPINBRUSH PRO WHITENING MEDIUM TOOTHBRUSH, POWERED JEQ CHURCH & DWIGHT CO., INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability