BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SOOTHIE PACIFIER

    MDR report key: 1802840 · Received August 10, 2010

    Report

    Report Number
    MW5017071
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 10, 2010
    Manufacturer
    LEARNING CURVE
    Product Code
    LQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(4) CHILD WAS BROUGHT INTO OUR EMERGENCY ROOM VIA AMBULANCE WITH A SUPER SOOTHIE PACIFIER WEDGED IN HER HYPOPHARYNX-POSTERIOR MOUTH-. EXTRACTION WAS ATTEMPTED BY PHYSICIAN AND RESPIRATORY THERAPIST USING MAGILL FORCEPS. THESE ATTEMPTS WERE UNSUCCESSFUL AS THEY KEPT SLIPPING OFF OF THE PACIFIER. OUR SURGEON ARRIVED. HE ATTEMPTED TO EXTRACT THE PACIFIER WITH THE MAGILL AND WAS ALSO UNSUCCESSFUL. THE SURGEON WAS ABLE TO USE A TONGUE BLADE AND PUSH THE TONGUE OUT OF THE WAY SO HE COULD CLAMP DOWN ON THE PACIFIER USING A KOCHER CLAMP AND WAS ABLE TO EXTRACT THE PACIFIER. THE PATIENT REMAINED ON OXYGEN AND WAS PLACED IN OBSERVATION CARE FOR A FEW HOURS OF CONTINUED MONITORING TO WATCH FOR THROAT SWELLING AND AIRWAY COMPROMISE. THE PATIENT WAS RELEASED FROM THE HOSPITAL FOUR HOURS AFTER THE EVENT IN THE CARE OF HER PARENTS. THE BABY DID SUFFER A FEW SCRAPES IN HER THROAT BUT NO PERMANENT DAMAGE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER SOOTHIE PACIFIER SOOTHIE LQX LEARNING CURVE Y4378

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Life Threatening| S