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 Code Available (3191)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

The customer purchased the smilefrida the toothhugger toothbrush and had been using it for 4-6 weeks once a day.The parent noticed that their son had chewed off a piece of the rubber tpe over-mold from the back and thought that he could have possibly ingested it.The child, while under supervision, was allowed to chew on the product even though the labeling clearly states the product is not a teether and should not be chewed or bitten.Chewing through the rubber tpe over-mold could be a potential choking hazard to children.

Event Description

Customer purchased the smilefrida the toothhugger and had been using it for 4-6 weeks once a day.The parent noticed that their son had chewed off a piece of the rubber tpe over-mold from the back and thought that he could have possibly ingested it.

• 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: 9603775
• MDR Text Key: 191969313
• Report Number: 3005630901-2019-00005
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• 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: 11/12/2018
• 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
• Patient Age: 21 MO