BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARM & HAMMER SPINBRUSH CLASSIC CLEAN

    MDR report key: 10186703 · Received June 23, 2020

    Report

    Report Number
    2280705-2020-00019
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 23, 2020
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE CONSUMER STATES THAT SHE BOUGHT THIS SPINBRUSH THIS PAST MARCH, BUT FIRST USED IT ON (B)(6) 2020. SHE HAS A "HEALING" POST ON HER LOWER GUM LINE, WHERE TOOTH #20 WAS (SECOND FROM THE BACK). SHE FURTHER STATED THAT WHILE BRUSHING, THE TOOTHBRUSH MUST HAVE TAKEN THE POST OUT IN SOME WAY. THE POST CAME OUT AND SHE WASN'T HURT. SHE HAD THE POST REPLACED BY HER DENTIST ON (B)(6) 2020. THE DENTIST USED ANESTHESIA DURING THE REPLACEMENT PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649235 ARM & HAMMER SPINBRUSH CLASSIC CLEAN POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC. 6687800350 DF8212E1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention