MAUDE Adverse Event Report: AUTOBRUSH FOR KIDS; TOOTHBRUSH, POWERED

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Airway Obstruction (1699); Foreign Body In Patient (2687)

Event Date 09/09/2021

Event Type  Injury  

Event Description

My (b)(6) son choked on the mouthpiece of the autobrush toothbrush.The mouthpiece is removable to allow for it to be cleaned.It popped off while my son was using it and lodged in his airway.I had to do the heimlich maneuver.This is very concerning because this toothbrush is marketed towards children and those with special needs.Fda safety report id# (b)(4).

• Brand Name: AUTOBRUSH FOR KIDS
• Type of Device: TOOTHBRUSH, POWERED
• MDR Report Key: 14219445
• MDR Text Key: 290299006
• Report Number: MW5109401
• Device Sequence Number: 1
• Product Code: JEQ
• 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: 04/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2022
• Patient Sequence Number: 1
• Treatment: MULTIVITAMIN
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 19 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White