BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRITESMILE LAMP & WHITENING GEL 25%

    MDR report key: 2650140 · Received May 10, 2012

    Report

    Report Number
    2032714-2012-00001
    Event Type
    Other
    Date Received
    May 10, 2012
    Date of Event
    March 22, 2012
    Report Date
    May 9, 2012
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATIVE INTERVIEW WITH THE DENTIST'S OFFICE FOLLOW UP TRAINING OVER THE PHONE WAS CONDUCTED AND DOCUMENTED IN THE COMPLAINT FILE.

    Description of Event or Problem · 1

    THE PT HAD THE WHITENING PROCEDURE PERFORMED ON OR BEFORE (B)(6) 2012, AT (B)(6) OFFICE. RIGHT AFTER THE PROCEDURE HER UPPER LIPS WERE SWOLLEN WITH SLIGHT WHITE SPOTS ON THE INNER LIP. HAD NO SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRITESMILE LAMP & WHITENING GEL 25% EEG DISCUS DENTAL, LLC BS4000 BS4000BS401665

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other BRITESMILE LED LAMP| BENADRYL| EXP. DATE: 06/06/2013| CORTIZONE| WHITENING PROCEDURE KIT 25%, LOT #11340019