BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 6123485 · Received November 22, 2016

    Report

    Report Number
    1000582314-2016-00009
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 22, 2016
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2016. THE INCIDENT OCCURRED DURING AN IN-OFFICE TEETH WHITENING PROCEDURE PERFORMED BY DENTAL ASSISTANT. THE BRUSH APPLICATOR CONTAINING HYDROGEN PEROXIDE, ACCIDENTALLY TOUCHED THE PATIENT'S LIP AND CAUSED A BURN WITH NO BLISTERS. THE DENTIST PRESCRIBED VICODIN. THE PATIENT IS HEALED, AND IS NOT EXPERIENCING ANY SYMPTOMS. THE RETAIN SAMPLE OF THE QUICKPRO VARNISH OF THE SAME LOT (SKU: 8810 716 01540, LOT: 16267008) WAS TESTED ON 11/07/2016 AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE GEL AND KIT WERE USED DURING THE PROCEDURE, AND WERE NOT RETURNED. BATCH HISTORY RECORD OF QUICKPRO VARNISH (LOT: 16267008) WAS REVIEWED, AND NO OUT OF SPECIFICATIONS, NON-CONFORMANCE OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINT HISTORY. NO OTHER SIMILAR COMPLAINTS WERE RECEIVED WITH THE SAME LOT NUMBER. BASED ON THE INVESTIGATION RESULTS, AND COMPLAINT DESCRIPTION IT CAN BE CONCLUDED THAT THERE WAS NO PRODUCT FAILURE OR MALFUNCTION. USER ERROR AND NOT FOLLOWING THE PROCEDURE CAUSED THIS INCIDENT. DFU IS ADEQUATE. DFU DESCRIBES THE STEPS FOR APPLYING THE WHITENING VARNISH USING BRUSH, AND AVOIDING SOFT TISSUE. IT ALSO INCLUDES WARNINGS, SAFETY DIRECTIONS, AND PRECAUTIONS. SINCE QUICKPRO WHITENING VARNISH IS COSMETICS AND NOT CLASSIFIED AS A MEDICAL DEVICE, "EIF" WAS SELECTED AS THE "PRODUCT CODE" IN SECTION OF THIS REPORT. DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS. THE WHITENING KIT WERE USED UP.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2016. THE INCIDENT OCCURRED DURING AN IN-OFFICE TEETH WHITENING PROCEDURE PERFORMED BY DENTAL ASSISTANT. THE BRUSH APPLICATOR CONTAINING HYDROGEN PEROXIDE, ACCIDENTALLY TOUCHED THE PATIENT'S LIP AND CAUSED A BURN WITH NO BLISTERS. HE DENTIST PRESCRIBED VICODIN. THE PATIENT IS HEALED, AND IS NOT EXPERIENCING ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771109 PHILIPS ZOOM QUICKPRO WHITENING VARNISH EIF DISCUS DENTAL, LLC 881071601540 16267008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other