BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 6470605 · Received April 6, 2017

    Report

    Report Number
    1000582314-2017-00004
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    March 6, 2017
    Report Date
    April 6, 2017
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 03/09/2017, IN WHICH THE PATIENT EXPERIENCED SWELLING, PAIN, AND IRRITATION OF LIP AND GINGIVA 2 DAYS AFTER THE IN-OFFICE ZOOM TEETH WHITENING PROCEDURE. THE SWELLING WAS MINOR, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. NO ADDITIONAL INFORMATION REGARDING MEDICAL TREATMENTS WAS REPORTED. INVESTIGATION: THE KIT AND GEL WERE USED UP DURING THE PROCEDURE AND WERE NOT RETURNED. THE RETAIN SAMPLE OF THE WHITENING GEL, SKU: 22-3764, LOT: 16335009, WAS TESTED ON 03/13/2017, AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED THE DEVICE/BATCH HISTORY RECORDS OF WHITENING KIT, SKU: ZM2666, LOT: 15323032, AND GEL, SKU: 22-3764, LOT: 16335009 WERE REVIEWED. NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINTS HISTORY OF THE LAST 2 YEARS, NO OTHER SIMILAR INCIDENT WAS REPORTED FROM THE SAME LOTS. REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES STEPS FOR TISSUE ISOLATION, CANDIDATE QUALIFICATION, WARNINGS, AND OTHER PRECAUTIONS. UPON REVIEW OF THE DEVICE HISTORY RECORD OF WHITENING KIT, SKU: ZM2666, LOT: 15323032, IT WAS NOTICED THAT THE EXPIRATION DATE OF THE KIT WAS ON 01/19/2017, WHILE THE PROCEDURE WAS PERFORMED ON (B)(6) 2017. THE DHR AND BILL OF MATERIAL CONFIRM THAT THE EXPIRATION DATE WAS INCLUDED ON THE PRODUCT LABELING. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. NO CORRECTIVE ACTIONS ARE REQUIRED. FAILURE TO FOLLOW THE INSTRUCTIONS PROVIDED WITH THE PRODUCT AND USE OF AN EXPIRED KIT, OR ANY PRE-EXISTING MEDICAL CONDITION OF THE PATIENT MAY HAVE CONTRIBUTED TO THIS ADVERSE EVENT. DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS. THE WHITENING KIT AND GEL WERE USED UP.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 03/09/2017, IN WHICH THE PATIENT EXPERIENCED SWELLING, PAIN, AND IRRITATION OF LIP AND GINGIVA 2 DAYS AFTER THE IN-OFFICE ZOOM TEETH WHITENING PROCEDURE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252202 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT AND GEL EEG DISCUS DENTAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other