BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SOOTHIE PACIFIER - OLDER THAN 3 MONTHS

    MDR report key: 1293899 · Received January 16, 2009

    Report

    Report Number
    MW5009664
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    December 26, 2008
    Report Date
    January 16, 2009
    Manufacturer
    PHILIPS CHILDREN'S MEDICAL VENTURES
    Product Code
    LQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON WAS GETTING FUSSY IN HIS CRIB. MY HUSBAND GAVE HIM A SOOTHIE PACIFIER, IT CLAIMED TO BE FOR BABIES OLDER THAN 3 MONTHS TO CALM HIM AND MY HUSBAND WENT BACK TO BED AT 6:00 AM. WITHIN A FEW MINUTES, WE HEARD OUR SON SCREAMING. MY HUSBAND WENT INTO OUR SON'S ROOM TO BRING HIM TO ME. I DISCOVERED THAT SOMEHOW THE ENTIRE SOOTHIE PACIFIER WAS LODGED IN HIS MOUTH. THERE WAS NOTHING SHOWING OF THE PACIFIER, BUT MY SON'S MOUTH COULD NOT SHUT. MY SON HAD VOMITED ENOUGH TO GET HAS CRIB SHEETS AND HIS PAJAMAS THOROUGHLY WET. I QUICKLY REMOVED THE PACIFIER FROM HIS MOUTH. LUCKILY, MY SON DID NOT CHOKE ON HIS VOMIT OR SUFFOCATE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CALM A FUSSY BABY. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER SOOTHIE PACIFIER - OLDER THAN 3 MONTHS NONE LQX PHILIPS CHILDREN'S MEDICAL VENTURES SUPER SOOTHIE

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other