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U.S. Department of Health and Human Services

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

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FRIDABABY FRIDABABY SMILEFRIDA THE TOOTHHUGGER; TOOTHBRUSH Back to Search Results
Model Number 017D
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Pain (1994)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
Customer reported that they gave their (b)(6) year old daughter her smilefrida the toothhugger toothbrush to brush her own teeth and that the customer was getting ready for work.Customer then reported that they noticed their daughter was saying 'ow' and looked over to see that she had chewed through the toothbrush head, thus exposing the small metal piece at the center of the toothbrush.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 and pp plastic, thereby exposing a small metal piece which could be a potential choking hazard to children.
 
Event Description
Customer reported that their (b)(6) year old daughter was brushing their own teeth with the smilefrida the toothhugger toothbrush without direct supervision and complained of pain, thus noticing the child had chewed through the toothbrush head.
 
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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, 22511 1
CH   225111
Manufacturer Contact
nicole greene
82 ne 26th street
suite 102
miami 33137
MDR Report Key9603783
MDR Text Key214805127
Report Number3005630901-2019-00014
Device Sequence Number1
Product Code EFW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number017D
Was Device Available for Evaluation? No
Date Manufacturer Received01/09/2020
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 Number1
Patient Age12 MO
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