BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM & HAMMER SPINBRUSH PRO CLEAN MEDIUM

    MDR report key: 10833817 · Received November 12, 2020

    Report

    Report Number
    2280705-2020-00031
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 12, 2020
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 STATED THAT WHILE BRUSHING HIS TEETH HE FELT SOMETHING HARD IN HIS MOUTH. HE ALLEGES THAT WHEN HE SPIT IT OUT HE SAW THAT IT WAS A SMALL SCREW. HE WAS NOT HURT IN THIS INCIDENT. AS PER OUR QA SPECIALIST, PICTURES OF THE BRUSH PROVIDED BY THE CONSUMER SHOW THAT THE PRODUCT HEAD SHOULD BE REPLACED (COLOR WEAR BRISTLE TECHNOLOGY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298983 ARM & HAMMER SPINBRUSH PRO CLEAN MEDIUM POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC. 6687800079 DD9205D1

    Patients

    Seq Age Sex Outcome Treatment
    1