SOPHIE THE GIRAFFE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for SOPHIE THE GIRAFFE manufactured by Unk.

Event Text Entries

[175049167] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5092146
MDR Report Key9570729
Date Received2020-01-08
Date of Report2020-01-08
Date of Event2019-12-11
Date Added to Maude2020-01-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOPHIE THE GIRAFFE
Generic NameRING, TEETHING, FLUID FILLED
Product CodeKKO
Date Received2020-01-08
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.