BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 7623659 · Received June 20, 2018

    Report

    Report Number
    1000582314-2018-00004
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    May 21, 2018
    Report Date
    June 20, 2018
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020034991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 05/24/2018, IN WHICH DENTAL ASSISTANT REPORTED THAT IN OFFICE TEETH WHITENING GEL DRIPPED ONTO PATIENT'S MANDIBLE. PATIENT EXPERIENCED SWOLLEN WHITE/GREY CERVICAL MARGINS. DENTIST RECOMMENDED MAGIC MOUTHWASH, PEROXYL AND CANKER SORE OTC DRUG. PATIENT IS DOING BETTER, PATIENT CONTINUES TO USE VITAMIN E OIL AND MAGIC MOUTHWASH. REVIEWED DIRECTION FOR USE OF THE IN-OFFICE WHITENING ZOOM CHAIRSIDE KIT. IT DESCRIBES THE STEPS FOR PROPER ISOLATION OF SOFT TISSUE TO PREVENT BURN AND IRRITATION. IT ALSO INCLUDES CANDIDATE QUALIFICATION, SAFETY DIRECTIONS, WARNINGS, AND PRECAUTIONS. REVIEWED DEVICE HISTORY RECORDS FOR WHITENING GEL PART NUMBER 22-3764, LOT NUMBER 18060002, AND ZOOM WHITENING KIT PART NUMBER 881055601540, LOT NUMBER 18060004, AND NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND. TESTED THE RETAIN SAMPLE OF THE WHITENING GEL 22-3764, LOT 18060002, AND NO PRODUCT FAILURE WAS DETECTED. REVIEWED CUSTOMER COMPLAINTS HISTORY FOR 2018, NO SIMILAR COMPLAINTS FROM THE SAME LOTS. WITH THE AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. NO CORRECTIVE ACTIONS ARE REQUIRED. THE POTENTIAL CAUSE OF THIS INCIDENT CAN BE FAILURE TO FOLLOW THE INSTRUCTIONS PROVIDED WITH THE PRODUCT. THE WHITENING KIT AND GEL WERE USED.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 05/24/2018, IN WHICH DENTAL ASSISTANT REPORTED THAT IN OFFICE TEETH WHITENING GEL DRIPPED ONTO PATIENT'S MANDIBLE. PATIENT EXPERIENCED SWOLLEN WHITE/GREY CERVICAL MARGINS. DENTIST RECOMMENDED MAGIC MOUTHWASH, PEROXYL AND CANKER SORE OTC DRUG. PATIENT IS DOING BETTER, PATIENT CONTINUES TO USE VITAMIN E OIL AND MAGIC MOUTHWASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461589 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT AND GEL EEG DISCUS DENTAL, LLC 881055601540 18060004 00075020034991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other