BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM & HAMMER "SPINBRUSH" PROCLEAN SONIC

    MDR report key: 3960503 · Received June 24, 2014

    Report

    Report Number
    2280705-2014-00026
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    TRISA AG
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINTS ARE MANUFACTURED AT THE FOLLOWING CONTRACT MANUFACTURING LOCATIONS.

    Description of Event or Problem · 1

    CONSUMER REPORTS THE HEAD BRISTLES AT THE TOP OF THE BRUSH CAME OUT. METAL ROD WENT THROUGH CHEEK AND POPPED OUT THE OTHER SIDE OF THE CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368080 ARM & HAMMER "SPINBRUSH" PROCLEAN SONIC TOOTHBRUSH, POWERED JEQ TRISA AG DD2331L1

    Patients

    Seq Age Sex Outcome Treatment
    1