inforMED
MalfunctionLQX

SUPER SOOTHIE PACIFIER - OLDER THAN 3 MONTHS

Received Jan 16, 2009 · Event occurred Dec 26, 2008

Report MW5009664 · MDR key 1293899

Device

Generic name

None

Model number

SUPER SOOTHIE

Product problems

  • Unknown (for use when the device problem is not known)

Patient

5 MO

  • Vomiting
  • Irritability
  • Choking

Narrative

Description of Event or Problem

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.