BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 6914176 · Received October 4, 2017

    Report

    Report Number
    1000582314-2017-00008
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    September 7, 2017
    Report Date
    October 4, 2017
    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 (B)(6) 2017 IN WHICH PATIENT HAD AN ALLERGIC REACTION AND BROKE OUT IN HIVES DURING IN-OFFICE TEETH WHITENING PROCEDURE. NO PAIN OR INJURY IN THE MOUTH OR LIPS WAS REPORTED. THE PATIENT TOOK BENADRYL AND WAS REFERRED TO SEE AN ALLERGIST BY HER DENTIST. NO INFORMATION WAS PROVIDED IF THE PATIENT VISITED A SPECIALIST OR NOT. THE DENTIST MENTIONED THAT THE PATIENT APPEARED ITCHY AND UNCOMFORTABLE BEFORE STARTING THE PROCEDURE. THE HIVES WERE CLEARED UP WITHIN THE NEXT DAY. INVESTIGATION: - THE PRODUCT WAS USED UP DURING THE PROCEDURE AND NOT AVAILABLE FOR RETURN. - THE RETAIN SAMPLE OF THE ZOOM WHITENING GEL, (B)(4), LOT: 17158007 WAS TESTED ON 9/13/2017 AND RESULTS WERE WITHIN SPECIFICATIONS. - REVIEWED DEVICE HISTORY RECORDS OF ZOOM WHITENING KIT, (B)(4), LOT: 17131017, ZOOM WHITENING GEL, (B)(4), LOT: 17158007 AND NO OUT OF SPECIFICATION WAS FOUND IN THE RECORDS. - REVIEWED RECEIVING RECORDS AND CERTIFICATE OF ANALYSIS OF LIQUIDAM AND NO OUT OF SPECIFICATION WAS FOUND. - REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENTS WERE REPORTED FROM THE SAME LOTS. - REVIEWED DIRECTION FOR USE OF THE KIT. THE DFU DESCRIBES CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, AND OTHER PRECAUTIONS. PRODUCT LABELING ALSO INCLUDES INGREDIENTS LIST. - POTENTIAL CAUSE OF THIS EVENT MAY BE AN ALLERGIC REACTION TO ONE OF THE PRODUCT INGREDIENTS. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. PRODUCT WAS USED UP DURING THE PROCEDURE.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017 IN WHICH PATIENT HAD AN ALLERGIC REACTION AND BROKE OUT IN HIVES DURING IN-OFFICE TEETH WHITENING PROCEDURE. NO PAIN OR INJURY IN THE MOUTH OR LIPS WAS REPORTED. THE PATIENT TOOK BENADRYL AND WAS REFERRED TO SEE AN ALLERGIST BY HER DENTIST. NO INFORMATION WAS PROVIDED IF THE PATIENT VISITED A SPECIALIST OR NOT. THE DENTIST MENTIONED THAT THE PATIENT APPEARED ITCHY AND UNCOMFORTABLE BEFORE STARTING THE PROCEDURE. THE HIVES WERE CLEARED UP WITHIN THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693299 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT AND GEL EEG DISCUS DENTAL, LLC 881055601540 17131017 00075020034991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other