BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 6455651 · Received April 3, 2017

    Report

    Report Number
    1000582314-2017-00003
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    March 6, 2017
    Report Date
    April 3, 2017
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 03/06/2017. THE INCIDENT OCCURRED DURING AN IN-OFFICE TEETH WHITENING PROCEDURE PERFORMED BY THE DENTAL HYGIENIST. THE PATIENT CLAIMED THE PROCEDURE WASN'T DONE CORRECTLY. THE LIQUIDAM WAS NOT APPROPRIATELY APPLIED, AND A LARGE AMOUNT OF GEL WAS APPLIED INSTEAD OF PAINTED. SHE FELT BURNING AS SOON AS THE WHITENING GEL WAS APPLIED. THE PATIENT VISITED HER DOCTOR AFTER THE INCIDENT, AND SHE IS USING FLUORIDE PASTE. NO OTHER INFORMATION REGARDING MEDICAL TREATMENT WAS REPORTED. INVESTIGATION: THE RETAIN SAMPLE OF THE QUICKPRO VARNISH OF THE SAME LOT (SKU: 8810 716 01540, LOT: 16351011) WAS TESTED ON 03/07/2017 AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE WHITENING KIT WAS USED DURING THE PROCEDURE AND WAS NOT RETURNED TO THE MANUFACTURER. BATCH HISTORY RECORD OF QUICKPRO VARNISH (LOT: 16351011) WAS REVIEWED, AND NO OUT OF SPECIFICATIONS, OR NON-CONFORMANCE 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. BASED ON THE INFORMATION PROVIDED BY THE PATIENT, IT CAN BE CONCLUDED THAT THE DENTAL HYGIENIST DID NOT FOLLOW THE PROCEDURE AS DESCRIBED IN THE DFU. DFU IS ADEQUATE. DFU DESCRIBES THE STEPS FOR ISOLATING GUMS USING LIQUIDAM, APPLYING THE WHITENING GEL USING THE BRUSH, AND AVOIDING SOFT TISSUE. IT ALSO INCLUDES WARNINGS, SAFETY DIRECTIONS, AND PRECAUTIONS. SINCE QUICKPRO WHITENING VARNISH IS COSMETIC AND NOT CLASSIFIED AS A MEDICAL DEVICE, "EIE" WAS SELECTED AS THE "PRODUCT CODE". DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS. THE WHITENING KIT WAS USED UP.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 03/06/2017. THE INCIDENT OCCURRED DURING AN IN-OFFICE TEETH WHITENING PROCEDURE PERFORMED BY THE DENTAL HYGIENIST. THE PATIENT CLAIMED THE PROCEDURE WASN'T DONE CORRECTLY. THE LIQUIDAM WAS NOT APPROPRIATELY APPLIED, AND A LARGE AMOUNT OF GEL WAS APPLIED INSTEAD OF PAINTED. SHE FELT BURNING AS SOON AS THE WHITENING GEL WAS APPLIED. THE PATIENT VISITED HER DOCTOR AFTER THE INCIDENT, AND SHE IS USING FLUORIDE PASTE. NO OTHER INFORMATION REGARDING MEDICAL TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237680 PHILIPS ZOOM QUICKPRO WHITENING VARNISH EIE DISCUS DENTAL, LLC 881071601540 16351011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other