BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A&H SPINBRUSH TRULY RADIANT CLN + REFILLS CLUB PACK

    MDR report key: 11203996 · Received January 20, 2021

    Report

    Report Number
    2280705-2021-00001
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    January 10, 2021
    Report Date
    February 4, 2022
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. PRODUCT COMPONENTS ARE MANUFACTURED AT THE FOLLOWING CONTRACT MANUFACTURING LOCATIONS. SINCE THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE, WE ARE UNABLE TO DETERMINE WHICH EXACT PRODUCT WAS USED AND AT WHICH LOCATION THE PARTICULAR PRODUCT WAS MANUFACTURED. HEADS ARE MANUFACTURED AT THE FOLLOWING LOCATION: CONTRACT MFR. TRISA AG KANTONSSTRASSE31 TRIENGEN, SWITZERLAND 6234. CONTRACT MFR. HAYCO LTD. 4F CITICORP CENTRE, 18 WHITFIELD RD. CAUSEWAY BAY, HONG KONG, CHINA. CONTRACT MFR. SHANTOU CITY KIN SENG PLASTIC CO., LTD. PIN BEI INDUSTRIAL AREA CHAO YANG COUNTY. UPDATED/SUPPLEMENTAL REPORT WITH SECTION G-6 COMPLETED.

    Description of Event or Problem · 0

    THE CONSUMER ALLEGES THAT THE SPINBRUSH TOOTHBRUSH BROKE HALF OF HIS/HER TEETH. IT WAS ALSO ALLEGED THAT IT SPINS TOO FAST AND THE BRISTLES ARE TOO HARD.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPONENTS ARE MANUFACTURED AT THE FOLLOWING CONTRACT MANUFACTURING LOCATIONS. SINCE THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE, WE ARE UNABLE TO DETERMINE WHICH EXACT PRODUCT WAS USED AND AT WHICH LOCATION THE PARTICULAR PRODUCT WAS MANUFACTURED. HEADS ARE MANUFACTURED AT THE FOLLOWING LOCATION: (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THAT THE SPINBRUSH TOOTHBRUSH BROKE HALF OF HIS/HER TEETH. IT WAS ALSO ALLEGED THAT IT SPINS TOO FAST AND THE BRISTLES ARE TOO HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100285 A&H SPINBRUSH TRULY RADIANT CLN + REFILLS CLUB PACK POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC. 6687800215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability