BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENING LAMP AND PROCEDURE KIT

    MDR report key: 1785048 · Received July 15, 2010

    Report

    Report Number
    2032714-2010-00002
    Event Type
    Other
    Date Received
    July 15, 2010
    Date of Event
    June 8, 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
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISCUS TECHNICAL SPECIALIST FOR ZOOM CHAIRSIDE WHITENING ((B)(4)) INVESTIGATED THE INCIDENT AND EVALUATED THE PROCESS/PROCEDURE(S) THAT (B)(6) OFFICE USED IN WHITENING THE PT'S TEETH. IT WAS STRONGLY RECOMMENDED THAT THE DFU FOR THE WHITENING PROCEDURE BE FOLLOWED; UP TO THE INCLUDING USING ALL MATERIALS PROVIDED; MOST SPECIFICALLY THE ISOLATION RETRACTORS. THE DFU PROVIDED WITH THE KIT WAS REVIEWED TO MAKE SURE IT CONTAINED BEST PRACTICE TECHNIQUES TO AVOID UV EXPOSURE TO LIPS AND GUMS AS WELL AS INITIAL AND FOLLOW-UP TRAINING.

    Description of Event or Problem · 1

    THE PT CLAIMS AS A RESULT OF THE PROCEDURE, THAT SHE EXPERIENCED SWELLING OF THE UPPER AND LOWER LIP WITH A BLISTER ON THE UPPER INSIDE OF THE LIP. THE DENTIST ((B)(6)) PRESCRIBED PERIDEX AND WARM SALT WATER TO USE. THE PT STATED THEY WENT TO THE EMERGENCY ROOM BECAUSE, THEIR LIP WAS STILL SWOLLEN BECAUSE (B)(6) "WAS NO HELP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING LAMP AND PROCEDURE KIT EEG DISCUS DENTAL, LLC ZM2550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization LOT: # 10018045, EXP. DATE: 07/2011| ZOOM WHITENING PROCEDURE KIT 25%, NDC# (B)(4)