BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 5504815 · Received March 16, 2016

    Report

    Report Number
    1000582314-2016-00002
    Event Type
    Injury
    Date Received
    March 16, 2016
    Date of Event
    February 10, 2016
    Report Date
    March 16, 2016
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WENT THROUGH A ZOOM TEETH WHITENING PROCEDURE ON (B)(6) 2016. THE PATIENT COMPLAINED ABOUT SWOLLEN LIPS THE NEXT DAY, AND VISITED URGENT CARE ON (B)(6) 2016. BENADRYL WAS PRESCRIBED IN THE URGENT CARE. THE PATIENT VISITED THE DENTIST ON (B)(6) 2016, AND THE LIPS WERE NO LONGER SWOLLEN. THE INCIDENT WAS REPORTED TO DISCUS DENTAL ON (B)(6) 2016. BATCH HISTORY RECORDS OF (B)(4) ZOOM WHITENING GEL, LOT # 15210013 AND (B)(4) ZOOM WHITENING KIT, LOT # 15217042 WERE REVIEWED. THE REVIEW OF THE BATCH HISTORY RECORD DID NOT UNCOVER ANY OUT OF SPECIFICATION CONDITION OR ADVERSE FINDING. IN ADDITION, THE RETAIN SAMPLE OF THE WHITENING GEL, LOT # 15210013 WAS TESTED ON 02/18/2016. THE RESULTS WERE WITHIN SPECIFICATIONS. NO OTHER QUALITY ISSUE WAS REVEALED DURING THE REVIEW OF THE RECORDS. CUSTOMER COMPLAINT LOG FROM (B)(6) 2015 TO (B)(6) 2016 WAS REVIEWED. NO OTHER SAFETY INCIDENTS HAVE BEEN REPORTED WITH THE SAME LOT NUMBERS. SIMILAR INCIDENT RATE IS (B)(4). (TOTAL SIMILAR INCIDENTS FROM 01/01/2015 TO 03/01/2016 DIVIDED BY TOTAL SALES OF ZOOM CHAIRSIDE KIT IN THE SAME PERIOD). THE TREND IS NEGATIVE COMPARE TO 2014 INCIDENT RATE WHICH WAS (B)(4). NOTES FROM DIRECTIONS FOR USE (DFU) OF THE ZOOM WHITENING KIT; PRECAUTIONS 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. VITAMIN E OIL APPLY VITAMIN E OIL TO LIPS TO MOISTURIZE BEFORE RETRACTION. TIP: IF PATIENT NOTES IRRITATION AT MARGIN USE VITAMIN E OIL TO SOOTH TISSUE. BASED ON THE INVESTIGATION AND INFORMATION PROVIDED, POSSIBLE ALLERGIC REACTION, PATIENT-DEVICE INCOMPATIBILITY, AND IMPROPER ISOLATION PRIOR TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THIS INCIDENT. SINCE THE PATIENT WENT TO URGENT CARE AND TOOK BENADRYL, THIS EVENT WILL BE REPORTED TO FDA. DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS. THE WHITENING KIT WAS USED.

    Description of Event or Problem · 1

    THE PATIENT WENT THROUGH A ZOOM TEETH WHITENING PROCEDURE ON (B)(6) 2016. THE PATIENT COMPLAINED ABOUT SWOLLEN LIPS THE NEXT DAY, AND VISITED URGENT CARE ON (B)(6) 2016. BENADRYL WAS PRESCRIBED IN THE URGENT CARE. THE PATIENT VISITED THE DENTIST ON (B)(6) 2016, AND THE LIPS WERE NO LONGER SWOLLEN. THE INCIDENT WAS REPORTED TO DISCUS DENTAL ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159583 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT EEG DISCUS DENTAL, LLC ZM2665 15217042

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization