BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER TOOTHBRUSH REPLACEMENT HEAD

    MDR report key: 3162499 · Received June 6, 2013

    Report

    Report Number
    1825660-2013-00049
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 4, 2013
    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 IS REPORTED AS A MALFUNCTION WITH THE POTENTIAL TO CAUSE SERIOUS INJURY. NO INJURY OCCURRED. TOOTHBRUSH HEAD WAS MORE THAN A YEAR OLD. THE PROBABLE ROOT CAUSE OF MALFUNCTION IS CUSTOMER ABUSE. INVESTIGATION FOUND THAT THE BRUSH DISK'S PULL OFF FORCE FOR THIS LOT MET REQUIREMENTS. MARKS SHOWN ON THE SURFACE OF THE BRUSH BODY INDICATE THE CUSTOMER CHEWED AND PRIED THE DISK LOOSE FROM THE BRUSH HEAD.

    Description of Event or Problem · 1

    CONSUMER HAS STATED THAT THEIR TODDLER WAS USING THIS AND THE HEAD OF THE BRUSH CAME OFF IN HER MOUTH. CUSTOMER STATES THIS WAS A POSSIBLE CHOKING HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251788 POWER TOOTHBRUSH REPLACEMENT HEAD JEQ RANIR LLC

    Patients

    Seq Age Sex Outcome Treatment
    1