MAUDE Adverse Event Report: HIGH RIDGE BRANDS / DR. FRESH LLC FIREFL LIGHT UP TIMER TOOTHBRUSH; TOOTHBRUSH, POWERED

Model Number 18171040

Device Problems Corroded (1131); Material Split, Cut or Torn (4008)

Patient Problem Chemical Exposure (2570)

Event Date 07/01/2019

Event Type  Injury  

Event Description

My (b)(6) old daughter was playing with a dr fresh llc.Firefly brand light up timer toothbrush and chewed through an elastomer over-molded suction cup on the handle of the toothbrush.The elastomer overmolding also acts as the battery enclosure.As my daughter chewed through the battery enclosure, the small pcb, led light, wiring, battery contacts, and button cell, batteries separated from the device and ended up in my daughter's mouth.My wife managed to fish all three button cell batteries and remaining components from my daughter's mouth before any were swallowed.We tore open another toothbrush to compare components and verify that we had found all the parts.Since this should be foreseeable misuse on the part of the mfr and since batteries, if swallowed, can cause death; i determined it was necessary to report to the fda.We also noticed corrosion on the batteries which leads me to believe that there was a small tear in the elastomer battery enclosure allowing water to enter and corrode the batteries before my daughter started chewing through the enclosure.Fda safety report id# (b)(4).

• Brand Name: FIREFL LIGHT UP TIMER TOOTHBRUSH
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): HIGH RIDGE BRANDS / DR. FRESH LLC
• MDR Report Key: 8758860
• MDR Text Key: 150235298
• Report Number: MW5087825
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18171040
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 MO
• Patient Weight: 14