MAUDE Adverse Event Report: SOPHIE THE GIRAFFE; RING, TEETHING, FLUID FILLED

Device Problem Fail-Safe Problem (2936)

Patient Problem Choking (2464)

Event Date 12/11/2019

Event Type  Injury  

Event Description

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).

• Brand Name: SOPHIE THE GIRAFFE
• Type of Device: RING, TEETHING, FLUID FILLED
• MDR Report Key: 9570729
• MDR Text Key: 175049167
• Report Number: MW5092146
• Device Sequence Number: 1
• Product Code: KKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 MO