BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITER IMAGE 40% PEROXIDE

    MDR report key: 19163630 · Received April 22, 2024

    Report

    Report Number
    MW5154077
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    April 14, 2024
    Report Date
    April 14, 2024
    Manufacturer
    PAC-DENT INC.
    Product Code
    MAU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A COMPANY IS SELLING 40% PEROXIDE AS A TOOTH WHITENER, AND A REVIEWER SAID IT BURNED AND DISCOLORED THEIR GUMS, LOOKS LIKE ITS BEING SOLD OTC (OVER-THE-COUNTER) DESPITE THE HIGH PEROXIDE IN IT. AMAZON IS SELLING IT: HTTPS://WWW.GOOGLE.COM/URL?SA=T&SOURCE=WEB&RCT=J&OPI=89978449&URL=HTTPS://WWW.AMAZON.COM/WHITER-IMAG E-PREMIUM-WHITENING-TREATMENT/DP/B0C9TSNB55&VED=2A HUKEWJBHIUZQSKFAXUJEMIAHRNJBRIQFNOECBKQAQ&USG=AOVV AW22WE9EXPN0SCYCE-MJ5AVW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329941 WHITER IMAGE 40% PEROXIDE ERASER, DENTAL STAIN MAU PAC-DENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose