BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENING LAMP AND PROCEDURE KIT

    MDR report key: 2026830 · Received March 15, 2011

    Report

    Report Number
    2032714-2011-00001
    Event Type
    Other
    Date Received
    March 15, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 25, 2011
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 DR (B)(6) STAFF USED IN WHITENING THE PATIENT'S TEETH. IT WAS DETERMINED DURING THE INTERVIEW PROCESS THAT THE RETRACTOR PROVIDED WITH THE KIT WAS NOT USED. THIS PARTICULAR RETRACTOR HAS BEEN (WAS) DESIGNED TO WRAP AROUND THE LIPS AND PROTECT THEM FROM UV LIGHT EMISSIONS FROM THE CHAIRSIDE LAMP. USING ANY "OFF LABEL" RETRACTORS NOT PROVIDED WITH THE KIT CAN INCREASE THE RISK FOR TISSUE EXPOSURE TO UV RAYS. THE KIT DOES CONTAIN A WARNING CARD TO THE END USER TO USE ALL ITEMS IN THE KIT, IN THE ORDER REQUIRED WITH NO SUBSTITUTIONS. IT WAS STRONGLY RECOMMENDED THAT THE DFU FOR THE WHITENING PROCEDURE BE FOLLOWED. THE DFU, MOST SPECIFICALLY ISOLATION REQUIREMENTS AND TECHNIQUES WERE REVIEWED WITH THE PERSON WHO ORIGINALLY PERFORMED THE PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT HAD THE PROCEDURE PERFORMED ON OR BEFORE (B)(6) 2011 AT (B)(6) OFFICE. SHE CALLED IN TO COMPLAIN TO (B)(6) OFFICE ON (B)(6) 2011 CLAIMING SHE HAD SWOLLEN LIPS WITH SLIGHT BLISTERING AND THAT SHE HAD GONE TO THE EMERGENCY ROOM BECAUSE OF IT.

    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 Hospitalization ONE KIT PER PROCEDURE, ONE AND A HALF HOURS| LOT # 10169306, EXP. DATE 06/2011, NDC # (B)(4)