BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT POWER BRUSH HEAD

    MDR report key: 3921937 · Received June 2, 2014

    Report

    Report Number
    1825660-2014-00839
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 2, 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 MFR. IT APPEARS THAT THE HEAD OF THE TOOTHBRUSH BROKE OFF. CONSUMER HAS STATED THAT SHE WILL RETURN THE DEVICE FOR EVALUATION, BUT DEVICE HAS NOT YET BEEN RECEIVED. NO INJURY WAS REPORTED, NO MED ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS IS BEING REPORTED AS A MALFUNCTION; CHOKING IS POSSIBLE AS A RESULT OF THE BREAKAGE.

    Description of Event or Problem · 1

    CONSUMER CALLED AND SAID THAT SHE USED THE BRUSH HEAD FOR FIVE WEEKS. LAST NIGHT THE BRUSH HEAD BROKE AT THE NECK OF THE DEVICE WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321822 REPLACEMENT POWER BRUSH HEAD POWERED TOOTHBRUSH, ACCESSORY JEQ RANIR LLC SMILESONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other