BEUDAMED
    FDA Adverse Event Summary report: N

    ZOOM CHAIRSIDE WHITENING

    MDR report key: 3862793 · Received June 10, 2014

    Report

    Report Number
    1000582314-2014-00008
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 19, 2014
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 01/01/2015. 07/01/2013. AN EXTENSIVE INVESTIGATION WAS CONDUCTED FOR COMPLAINT #(B)(4). ON (B)(6) 2014, THE OFFICE REPORTED THAT A PATIENT'S FRONT TOOTH IS TRANSLUCENT AFTER ZOOM TREATMENT. THE DENTAL OFFICE DISPOSED THE ZOOM WHITENING CHAIRSIDE LOT INFORMATION. IN ORDER TO INITIATE TESTING OF THE RETAINS, THE SALES HISTORY FOR THE DENTAL OFFICE IN THE LAST 12 MONTHS WAS REVIEWED. IT WAS DECIDED TO TEST ALL THREE LOTS THAT WERE SHIPPED TO THE DENTAL OFFICE IN THE LAST 12 MONTHS. THE INVESTIGATION INCLUDED REVIEW OF BATCH HISTORY RECORD FOR CHAIRSIDE GEL 22-3764 LOT #S 14069020, 13203060 AND 13129001. IN ADDITION, THE RETAIN SAMPLE FOR SKU #22-3764 LOT #S 14069020, 13203060 AND 13129001 WERE TESTED AND THEY WERE FOUND TO BE WITHIN SPECIFICATIONS. NO OTHER QUALITY ISSUE WAS REVEALED DURING THE REVIEW OF SAID RECORDS. THE COMPLAINT RECORD STATES THAT THE PATIENT'S TEETH WERE WHITE BEFORE THE WHITENING PROCEDURE SO THERE WAS NO NEED TO TAKE BEFORE PHOTOS. BASED ON THE INVESTIGATION, IT APPEARS THS IS AN ISOLATED INCIDENT. DISCUS DENTAL WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE OFFICE REPORTED THAT A PATIENT'S FRONT TOOTH IS TRANSLUCENT AFTER ZOOM TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339183 ZOOM CHAIRSIDE WHITENING ZOOM CHAIRSIDE WHITENING EEG DISCUS DENTAL, LLC 14069020, 13203060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other