BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A&H SPINBRUSH PRO WHITENING SOFT

    MDR report key: 11517148 · Received March 18, 2021

    Report

    Report Number
    2280705-2021-00008
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 6, 2021
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED BECAUSE WE RECEIVED ADDITIONAL INFORMATION REGARDING THE SPECIFIC PRODUCT NAME AND UPC NUMBER.

    Description of Event or Problem · 0

    THE CONSUMER ALLEGES THAT THIS TOOTHBRUSH CHIPPED THE BACK TOOTH ON THE BOTTOM LEFT SIDE. SHE NOTICED THE CHIPPED TOOTH TWO HOURS AFTER USING THE TOOTHBRUSH. SHE ALSO REPORTED PAIN WITH THE CHIPPED TOOTH. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THAT THIS TOOTHBRUSH CHIPPED THE BACK TOOTH ON THE BOTTOM LEFT SIDE. SHE NOTICED THE CHIPPED TOOTH TWO HOURS AFTER USING THE TOOTHBRUSH. SHE ALSO REPORTED PAIN WITH THE CHIPPED TOOTH. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414333 A&H SPINBRUSH PRO WHITENING SOFT POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC. 6687800191 DD0177D2

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Disability