BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM & HAMMER SPINBRUSH PRO CLEAN

    MDR report key: 10920167 · Received November 30, 2020

    Report

    Report Number
    2280705-2020-00032
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 10, 2020
    Report Date
    November 30, 2020
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 ACTUALLY OCCURRED. ADDITIONAL INFORMATION: PRODUCT COMPONENTS ARE MANUFACTURED AT THE FOLLOWING CONTRACT MANUFACTURING LOCATIONS. SINCE THE CONSUMER HAS NOT RETURNED THE PRODUCT, 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)(6).

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THAT WHILE BRUSHING HIS TEETH ONE OF THE PIECES OF MATERIAL ON THE TOOTHBRUSH FELL INTO THE SINK. HE DID NOT SWALLOW IT. WE ARE REPORTING THIS BASED ON THE LIMITED INFORMATION AND ALLEGATION OF A MALFUNCTION (SMALL PART BREAKAGE) WITH THE POTENTIAL TO CAUSE SERIOUS INJURY (CHOKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384547 ARM & HAMMER SPINBRUSH PRO CLEAN POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1