BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM & HAMMER SPINBRUSH SONIC BATTERY UNSPECIFIED

    MDR report key: 8946660 · Received August 29, 2019

    Report

    Report Number
    2280705-2019-00024
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 18, 2019
    Report Date
    August 29, 2019
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 TO CHURCH & DWIGHT CO., INC. 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 (B)(4). CONTRACT MFR. HAYCO LTD. (B)(4). CONTRACT MFR. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT WHILE USING THE TOOTHBRUSH THE HEAD CAME OFF AND THE METAL PIECE CUT HIM ON HIS RIGHT CHEEK. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740248 ARM & HAMMER SPINBRUSH SONIC BATTERY UNSPECIFIED POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR