BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORAL B

    MDR report key: 1192143 · Received October 7, 2008

    Report

    Report Number
    MW5008569
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ORAL B LABORATORIES
    Product Code
    JES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER BEGAN SERIOUSLY CHOKING ON AN ORAL B DENTAL FLOSS BLADE. MY SON WHO GOT INTO OUR DENTAL FLOSS AND TOOK APART THE ORAL B SATIN FLOSS CONTAINER. THE FLOSS ROLL, THE BLADE CAME APART VERY EASILY. WE CAUGHT HIM TAKING IT APART, NOT KNOWING THAT THE BLADE CAME OUT SO EASILY. SHE FOUND IT AND SWALLOWED IT. IT GOT CAUGHT ON HER GATE VALVE IN HER TRACHEA. IT REQUIRED EMERGENCY SURGERY, WHICH ACCORDING TO THE SURGEON USUALLY ONLY TAKES 10-15 MINUTES FOR THE LIKES OF A COIN TOOK OVER 45 MINUTES AND WAS VERY DIFFICULT TO OBTAIN. NO PERMANENT DAMAGE IS FELT TO BE SUSTAINED, JUST AN IMMEDIATE LARGE CHOKE HAZARD. THE DEVICE IS A TRIAL SIZE THAT MANY CARRY AROUND WITH THEM, THEY COME APART EASILY. THE ITEM IS A GOOD ITEM, HOWEVER NEEDS TO BE PERMANENTLY SEALED, SO A HAZARD CAN BE AVOIDED. PLEASE LET ME KNOW ANY OUTCOME. I AM PT'S FATHER AND CAN BE CONTACTED. MY WIFE ALSO CONTACTED ORAL B'S HOTLINE TODAY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORAL B DENTAL FLOSS TRIAL PACKET JES ORAL B LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Life Threatening| S