BEUDAMED
    FDA Adverse Event Summary report: N

    ZOOM CHAIRSIDE WHITENING

    MDR report key: 5084416 · Received September 17, 2015

    Report

    Report Number
    1000582314-2015-00003
    Date Received
    September 17, 2015
    Date of Event
    August 18, 2015
    Report Date
    September 17, 2015
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXTENSIVE INVESTIGATION WAS CONDUCTED FOR (B)(4). ON (B)(6) 2015, CUSTOMER CALLED STATING THAT A PATIENT WAS STILL EXPERIENCING SENSITIVITY 60 DAYS AFTER THE ZOOM CHAIRSIDE WHITENING PROCEDURE WAS PERFORMED. THE INVESTIGATION INCLUDED REVIEW OF BATCH HISTORY RECORD FOR ZM2666 ZOOM CH KIT DW 14% TU 2PK NA LOT # 15142012 (CHAIRSIDE GEL 22-3764 LOT # 15133017). THE REVIEW OF THE BATCH HISTORY RECORD DID NOT UNCOVER ANY OOS CONDITION OR ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE FOR SKU # 22-3764 LOT #15133017 WAS TESTED AND IT WAS FOUND TO BE WITHIN SPECIFICATIONS. NO OTHER QUALITY ISSUE WAS REVEALED DURING THE REVIEW OF SAID RECORDS. ALSO REVIEWED CUSTOMER COMPLAINT LOG FROM 04/2013 TO 09/2015. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED. A REVIEW OF THE DIRECTIONS FOR USE (DFU) SHOWS THE FOLLOWING STATEMENT IN THE DFU: IMPROPER ISOLATION MAY RESULT IN BURNING OF THE GINGIVA OR SWOLLEN LIPS DUE TO UV LIGHT COMING IN CONTACT WITH TISSUE OR CHEMICAL BURN DUE TO WHITENING GEL COMING IN CONTACT WITH TISSUE. PATIENTS MORE SUSCEPTIBLE TO SENSITIVITY ARE THOSE WITH: KNOWN HYPERSENSITIVITY, UNTREATED CARIES, EXPOSED ROOT SURFACES, DEFECTIVE RESTORATIONS, ORAL TISSUE INJURY, UNTREATED PERIODONTAL DISEASE. IT ALSO STATES: TREAT FOR SENSITIVITY IT IS RECOMMENDED TO PRESCRIBE THE FOLLOWING PRIOR TO THE PROCEDURE: 5000 PPM FLUORIDEX DAILY DEFENSE SENSITIVITY RELIEF WITH 5% KNO3. INSTRUCT USE OF 2X/DAY, 14 DAYS PRIOR 600MG OF IBUPROFEN 1 HOUR PRIOR TRAYS WITH RELIEF ACP 10-30 MINUTES PRIOR FOR EXTRA SENSITIVE PATIENTS BASED ON THE INVESTIGATION AND INFORMATION PROVIDED, IT APPEARS THAT THE DENTIST DID NOT FOLLOW THE COMPLETE SENSITIVITY PROTOCOL AS STATED IN THE DFU FOR THIS COSMETIC PROCEDURE. SINCE THE SENSITIVITY LASTED MORE THAN 60 DAYS, THIS EVENT WILL BE REPORTED TO THE FDA. DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    ONE PATIENT WAS EXPERIENCING SENSITIVITY 60 DAYS AFTER THE ZOOM CHAIRSIDE WHITENING PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616701 ZOOM CHAIRSIDE WHITENING ZOOM CHAIRSIDE KIT EEG DISCUS DENTAL, LLC ZM2666 15142012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other