MAUDE Adverse Event Report: TEETH WHITENING KIT; ERASER, DENTAL STAIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sensitivity of Teeth (2427)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

Painful teeth for 2 weeks; i bought a teeth whitening kit, which was fda approved / registered from this (b)(6) website: (b)(6) they claim they are fda registered which is not true, but i also understand they are abusing your fda logo to gain credibility.They use the fda logo 5 times, and that's just on the homepage.Fda safety report id# (b)(4).

• Brand Name: TEETH WHITENING KIT
• Type of Device: ERASER, DENTAL STAIN
• MDR Report Key: 10586365
• MDR Text Key: 208809346
• Report Number: MW5096880
• Device Sequence Number: 1
• Product Code: MAU
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other