BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT POWER BRUSH HEAD

    MDR report key: 3912055 · Received May 13, 2014

    Report

    Report Number
    1825660-2014-00826
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS NOT BEEN CONFIRMED. DEVICE NOT RETURNED TO MANUFACTURER. IT APPEARS THAT THE HEAD OF THE TOOTHBRUSH BROKE OFF, OR THE DISK BECAME DETACHED. CONSUMER HAS STATED THAT SHE WILL RETURN THE DEVICE FOR EVALUATION, BUT DEVICE HAS NOT YET BEEN RECEIVED. NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS IS BEING REPORTED AS A MALFUNCTION; CHOKING IS POSSIBLE AS A RESULT OF THE DISK DETACHMENT.

    Description of Event or Problem · 1

    NOTICED THEY LOOKED A LITTLE WEIRD AND USED IT ANYWAY. PUT ON HIS TOOTHBRUSH GENTLE AND IT BROKE HIS TOOTHBRUSH. LOOKED AT THE HEAD AND IT LOOKS BROKEN TOO NEAR THE BRISTLES AND THE PLASTIC PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285309 REPLACEMENT POWER BRUSH HEAD POWERED TOOTHBRUSH, ACCESSORY JEQ RANIR, LLC EASYFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other