BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 5814698 · Received July 21, 2016

    Report

    Report Number
    1000582314-2016-00005
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    August 1, 2015
    Report Date
    July 21, 2016
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT STATED SHE LOST THE ENAMEL GLOSS OF HER TWO TOP FRONT TEETH (# 8 AND 9 TEETH), AFTER GOING THROUGH ZOOM WHITENING PROCEDURE IN EARLY (B)(6) 2015. NO OTHER SERIOUS INJURY AND DAMAGE TO THE BODY WAS REPORTED TO THE CUSTOMER. THIS EVENT WAS REPORTED TO MANUFACTURER ON JUNE 23RD, 2016. THE KIT AND GEL WERE USED DURING THE PROCEDURE, AND WERE NOT RETURNED. NO SPECIFIC INFORMATION REGARDING THE LOT NUMBERS USED DURING THE WHITENING PROCEDURE IS PROVIDED AT TIME OF THIS REPORT. THREE POTENTIAL LOTS WERE IDENTIFIED BASED ON THE DENTIST'S SALES HISTORY ON JUNE AND JULY 2015. RETAIN SAMPLES OF WHITENING GELS FROM THESE 3 LOTS WERE TESTED ON 7/21/2016, AND RESULTS WERE WITHIN SPECIFICATIONS. DEVICE HISTORY RECORDS OF THESE 3 KITS AND GELS WERE REVIEWED, AND NO DISCREPANCY OR OUT OF SPECIFICATION CONDITION WAS FOUND. REVIEWED COMPLAINTS HISTORY OF THE PAST 3 YEARS. NO OTHER SIMILAR INCIDENT WAS REPORTED IN THE PAST. PER CLINICAL EXPERT ASSESSMENT, DIRECTOR OF CONSUMER AND DENTAL AFFAIRS, THE LOSS OF ENAMEL GLOSS CANNOT HAPPEN DUE TO PH OF THE WHITENING GEL. DENTIST STATED THAT IT SEEMS THAT A DENTAL BONDING WAS PREVIOUSLY APPLIED ON THE PATIENT'S FRONT TOOTH (# 8 TOOTH). NO OTHER KNOWN PRE-EXISTING CONDITION. BASED ON THE INVESTIGATION AND INFORMATION PROVIDED, NO MALFUNCTION, FAILURE, OR OUT OF SPECIFICATION WAS FOUND IN THE PRODUCT. THIS INCIDENT IS BEING REPORTED, SINCE THE PRODUCT MAY HAVE CAUSED AN ENAMEL GLOSS LOSS. DISCUS DENTAL WILL CONTINUE TO MONITOR COMPLAINTS HISTORY FOR SIMILAR COMPLAINTS. THE WHITENING KIT AND GEL WERE USED UP.

    Description of Event or Problem · 1

    THE PATIENT STATED SHE LOST THE ENAMEL GLOSS OF HER TWO TOP FRONT TEETH (# 8 AND 9 TEETH), AFTER GOING THROUGH ZOOM WHITENING PROCEDURE IN EARLY (B)(6) 2015. THIS EVENT WAS REPORTED TO MANUFACTURER ON JUNE 23RD, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465533 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT EEG DISCUS DENTAL, LLC ZM2666

    Patients

    Seq Age Sex Outcome Treatment
    1 Other