BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARM 7 HAMMER SPINBRUSH PROCLEAN

    MDR report key: 3841063 · Received May 16, 2014

    Report

    Report Number
    2280705-2014-00021
    Event Type
    Injury
    Date Received
    May 16, 2014
    Report Date
    May 16, 2014
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER FROM (B)(6) REPORTED TO CHURCH & DWIGHT CO., INC. (B)(6) THAT "THE ROUND PART OF THE BRUSH BROKE OFF IN HER MOUTH AND BROKE HER LOWER LEFT SIDE TOOTH. IT IS THE SECOND TOOTH FROM THE BACK". CONSUMER INDICATED THAT THE TOOTH THAT BROKE HAD PREVIOUSLY BEEN REPAIRED WITH A FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293016 ARM 7 HAMMER SPINBRUSH PROCLEAN TOOTHBRUSH, POWERED JEQ DD1312R2

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability