BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARM & HAMMER SPINBRUSH PRO UNSPECIFIED

    MDR report key: 9349313 · Received November 20, 2019

    Report

    Report Number
    2280705-2019-00030
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 20, 2019
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 BY 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: (B)(4). ALSO, DEVICE EVALUATION HAS NOT YET BEGUN SINCE WE'RE STILL WAITING TO RECEIVE THE DEVICE FROM THE CONSUMER.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT HIS TOOTH SPLIT IN TWO PIECES WHILE BRUSHING HIS TEETH. HE ALSO REPORTED BEING IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145392 ARM & HAMMER SPINBRUSH PRO UNSPECIFIED POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability