BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSURE

    MDR report key: 1570726 · Received January 2, 2010

    Report

    Report Number
    MW5014148
    Event Type
    Injury
    Date Received
    January 2, 2010
    Date of Event
    September 15, 2008
    Report Date
    January 2, 2010
    Product Code
    KYX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED A MEDICINE DROPPER, RESEMBLING A SYRINGE WITH A RUBBER BALL TO SQUEEZE THE MEDICINE IN AND OUT OF THE DROPPER. IT COMES APART FOR WASHING I GUESS. THE PT PULLED IT APART AND SWALLOWED THE RUBBER PART. SHE NEARLY CHOKED TO DEATH, WE COULDN'T GET IT OUT AND THE EMT WAS CALLED. MOST PHARMACIES WERE GIVING THESE OUT FREE WITH A LIQUID RX. I DROVE TO EVERY PHARMACY IN OUR TOWN TELLING THEM WHAT HAPPENED. SOME CHANGED TO THE SPOON, BUT IT NEEDS TO BE RECALLED. THEY ARE VERY DANGEROUS. EVERY DR AND PHARMACIST THAT I SPOKE WITH ABOUT THIS INCIDENT SAID, THEY GIVE THEM OUT AND HAD NEVER THOUGHT OF THE CHOKING HAZARD IT POSES. PT NEARLY DIED, IT WAS TERRIFYING, AND I HOPE YOU CAN DO SOMETHING TO PREVENT THIS FROM EVER HAPPENING TO ANOTHER FAMILY. THANK YOU. I TRIED TO REPORT THIS BEFORE, BUT IT WAS VERY DIFFICULT. I WAS PASSED ON PHONE TO ONE AGENCY THEN THE NEXT. NO ONE KNEW WHO I SHOULD REPORT THIS TOO. THE PT ALMOST DIED, WHY IS THIS SO DIFFICULT. I'VE ASKED EVERY PHARMACY, NO ONE TELL ME WHERE THESE ARE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSURE MEDICINE DROPPER KYX

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Life Threatening| S