BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENING LAMP AND PROCEDURE KIT

    MDR report key: 1785066 · Received July 15, 2010

    Report

    Report Number
    2032714-2010-00003
    Event Type
    Other
    Date Received
    July 15, 2010
    Date of Event
    May 31, 2010
    Report Date
    July 9, 2010
    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

    THE DISCUS TECHNICAL SPECIALIST FOR ZOOM CHAIRSIDE WHITENING (TREVOR RUCKER) INVESTIGATED THE INCIDENT AND EVALUATED THE PROCESS/PROCEDURE(S) THAT DR. (B)(6)'S OFFICE USED IN WHITENING THE PT'S TEETH. IT WAS STRONGLY RECOMMENDED THAT THE DFU FOR THE WHITENING PROCEDURE BE FOLLOWED. IT COULD NOT BE DETERMINED BY INTERVIEW AS TO WHY THE LIPS WERE SWOLLEN WITH BLISTERS, SINCE PROPER PROCEDURE AND MATERIALS WERE USED AS DIRECTED; HOWEVER, THE GUM IRRITATION AND SENSITIVITY MAY HAVE OCCURRED BECAUSE THE BARRIER MATERIAL WAS APPLIED TOO THICK, POSSIBLY RESULTING IN SOME HIGH HEAT TO THE GUMS WHEN THE UV LIGHT WAS ACTIVATED. THE DFU WAS REVIEWED TO MAKE SURE IT CONTAINED BEST PRACTICE TECHNIQUES TO AVOID UV EXPOSURE TO THE GUMS AS WELL AS INITIAL TRAINING AND FOLLOW-UP TRAINING RECOMMENDATIONS.

    Description of Event or Problem · 1

    THE PT HAD THE PROCEDURE ON (B)(6) 2010 AND CAME BACK TO DR. (B)(6)'S OFFICE ON (B)(6) 2010 COMPLAINING OF A BURNING SENSATION IN THE UPPER AND LOWER LIPS AND A BURNING SENSATION/PAIN IN RIGHT BUCCAL AND LINGUAL (GUMS). DR LYEW PRESCRIBED 400 MG IODINE. LATER THAT EVENING, THE PT WENT TO THE EMERGENCY ROOM CLAIMING SHE COULD NOT BREATHE DUE TO SWELLING OF HER LIPS. THE EMERGENCY ROOM PERSONNEL (DR.) PRESCRIBED PREGNAZONE, VICODIN AND CLENDAMIDACINE. DR. (B)(6) DID NOT REPORT THIS INCIDENT TO DISCUS DENTAL UNTIL (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING LAMP AND PROCEDURE KIT EEG DISCUS DENTAL, LLC ZM2604P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization ZOOM WHITENING PROCEDURE KIT 25%| (B)(4)