BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM & HAMMER SPINBRUSH SONIC

    MDR report key: 3955808 · Received June 5, 2014

    Report

    Report Number
    2280705-2014-00025
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    August 21, 2014
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPONENTS ARE MANUFACTURED AT THE FOLLOWING CONTRACT MANUFACTURING LOCATIONS. THE HEAD WAS MADE AT THE FOLLOWING LOCATION. CONTRACT MANUFACTURER: TRISA (B)(4). THE HANDLE WAS MADE AT THE FOLLOWING LOCATION. CONTRACT MANUFACTURER: HAYCO LTD.,(B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTS THE HEAD BRISTLES AT THE TOP OF THE BRUSH CAME OUT. THIS IS REPORTED AS MALFUNCTION WITH THE POTENTIAL TO CAUSE SERIOUS INJURY. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329503 ARM & HAMMER SPINBRUSH SONIC TOOTHBRUSH, POWERED JEQ 30801A

    Patients

    Seq Age Sex Outcome Treatment
    1