BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINBRUSH PRO CLEAN REPLACEMENT HEAD SOFT

    MDR report key: 11816055 · Received May 13, 2021

    Report

    Report Number
    2280705-2021-00017
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 28, 2021
    Report Date
    June 8, 2021
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, LOT CODE NUMBER AND MANUFACTURING DATE. AN INVESTIGATION OF THE PRODUCT WAS ALSO CONDUCTED.

    Description of Event or Problem · 0

    PRODUCT RECEIVED AND EVALUATED. THE EVALUATION DOES NOT CHANGE INITIAL REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT A PIECE BROKE OFF THE SPINBRUSH WHILE HE WAS USING IT AND THAT HE ALMOST SWALLOWED THE BROKEN PIECE. HE HAD TO SPIT THE PIECE OUT AND IT CUT THE INSIDE OF HIS MOUTH IN THREE PLACES. THE PIECE THAT BROKE OFF WAS FROM THE BACK OF THE REPLACEMENT TOOTHBRUSH HEAD. HE DID NOT SEEK MEDICAL ATTENTION AND HIS SYMPTOMS HAVE SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718799 SPINBRUSH PRO CLEAN REPLACEMENT HEAD SOFT POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC. 6687800080 DD9310A2

    Patients

    Seq Age Sex Outcome Treatment
    1