FDA Adverse Event Injury Summary report: N

SOPHIE THE GIRAFFE

MDR report key: 9570729 · Received January 8, 2020

Report

Report Number
MW5092146
Event Type
Injury
Date Received
January 8, 2020
Date of Event
December 11, 2019
Report Date
January 8, 2020
Manufacturer
UNK
Product Code
KKO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MT, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY SON, WHO IS (B)(6) MONTHS OLD, WAS TEETHING/CHEWING ON A STANDARD MODEL OF SOPHIE THE GIRAFFE WHEN AT SOME POINT HE PUT THE FRONT LEG IN HIS MOUTH AND IT GOT STUCK, AND HE COULD NOT GET IT OUT. I WAS SITTING NEXT TO HIM WHEN I HEARD AN ODD NOISE THAT HE STARTED MAKING, WHEN I REALIZED HE WAS CHOKING. I PULLED THE TOY OUT OF HIS MOUTH, AND HE WAS ABLE TO BREATHE AGAIN. WHEN I LOOKED AT THE SOPHIE WEBSITE THEY ADVERTISE THAT THE TOY IS APPROPRIATE FOR CHILDREN AGED THREE MONTHS ONWARDS. THEY ALSO ADVERTISE THAT THE LEGS ARE LONG ENOUGH SO THEY CAN REACH THE BACK MOLARS WHEN THE CHILD PUTS IT IN THEIR MOUTH. WHAT I FOUND EVEN MORE DISCOURAGING IS THAT AS I READ, I LEARNED THAT MANY CHILDREN HAVE CHOKED ON THIS PRODUCT. I READ ONE INCIDENT REPORT WHERE A MOTHER FOUND HER CHILD TURNING BLUE IN THE FACE BECAUSE THEY HAD BEEN CHOKING ON IT MUCH LONGER. HOW HAS THIS TOY NOT BEEN INVESTIGATED YET? DO WE REALLY HAVE TO WAIT FOR A CHILD TO DIE TO THEN STATE THAT SOPHIE IS NOT SAFE? THIS WAS A VERY UPSETTING EXPERIENCE AND I DON'T WANT ANY PARENT TO HAVE A WORSE OUTCOME THAN WHAT MY CHILD WENT THROUGH. MULTIPLE CHILDREN ARE CHOKING ON THE SAME MODEL, THE PRODUCT NEEDS TO BE PULLED AND REDESIGNED. THE PRODUCT IS A SOPHIE THE GIRAFFE AND THE EXACT PRODUCT CAN BE FOUND AT THIS WEBSITE: HTTPS://SOPHIETHEGIREFFE-USA.COM/COLLECTIONS/SOPUR-BOX-SET/PRODUCTS/SOPHIE-LA-GIRAFE-SOPURE-BOX-NEW. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
29574 SOPHIE THE GIRAFFE RING, TEETHING, FLUID FILLED KKO UNK

Patients

Seq Age Sex Outcome Treatment
1 5 MO