MAUDE Adverse Event Report: FRIDABABY FRIDABABY SMILEFRIDA THE TOOTHHUGGER; TOOTHBRUSH

Model Number 017

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

The customer purchased the smilefrida the toothhugger toothbrush from (b)(6).The customer then reported that they were allowing their daughter to chew on the toothbrush head.The customer then took the toothbrush away and noticed the metal strip that is welded into the inside of the toothbrush head, underneath the white pp plastic and yellow type over-mold was coming out from the toothbrush head.The child, while under supervision, was allowed to chew on the product even though the labeling clearly states that the product is not a teether and should not be chewed or bitten.Chewing through the rubber type over-mold and pp plastic, thereby exposing a small metal piece which could be a potential choking hazard to children.

Event Description

Customer reported that they purchased the smilefrida the toothhugger from (b)(6).The customer said that they were allowing their daughter to chew on the toothbrush head, the parent then took the toothbrush away and noticed the metal strip coming out from the toothbrush head.

• Brand Name: FRIDABABY SMILEFRIDA THE TOOTHHUGGER
• Type of Device: TOOTHBRUSH
• Manufacturer (Section D): FRIDABABY; 82 ne 26th street; suite 102; miami FL 33137
• Manufacturer (Section G): JIANGSU PROVINCE YANGZHOU SHUGUANG TOOTHBRUSH MANU; no. 1, cheng xi road; hangji town; yangzhou, jiangsu 22511 1; CH 225111
• Manufacturer Contact: nicole greene ; 82 ne 26th street; suite 102; miami,
• MDR Report Key: 9603785
• MDR Text Key: 207340685
• Report Number: 3005630901-2019-00004
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1