BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 7008133 · Received November 7, 2017

    Report

    Report Number
    1000582314-2017-00009
    Event Type
    Injury
    Date Received
    November 7, 2017
    Date of Event
    October 12, 2017
    Report Date
    November 7, 2017
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020035004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2017 IN WHICH DENTAL HYGIENIST REPORTED THAT AFTER IN-OFFICE TEETH WHITENING PROCEDURE, PATIENT FELT NAUSEOUS AND WENT TO HOSPITAL AFTER VOMITING BLOOD. THE PATIENT ALSO EXPERIENCED BURNING ON TONGUE AND ROOF OF THE MOUTH. THE DENTAL ASSISTANT STATED THAT THE PATIENT SWALLOWED THE GEL AND HAD A LOT OF SALIVATION DURING THE WHITENING PROCEDURE. INVESTIGATION: THE PRODUCT WAS USED UP DURING THE PROCEDURE AND NOT AVAILABLE FOR RETURN. THE RETAIN SAMPLE OF THE ZOOM WHITENING GEL, SKU: (B)(4), LOT: 17243014 WAS TESTED ON 10/17/2017 AND RESULTS WERE WITHIN SPECIFICATIONS. REVIEWED DEVICE HISTORY RECORDS OF ZOOM WHITENING KIT, SKU: 881055701540, UDI: (01)(B)(4), LOT: 17243005, AND ZOOM WHITENING GEL, SKU: (B)(4), LOT: 17243014 AND NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND IN THE RECORDS. REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENTS WERE REPORTED FROM THE SAME LOTS. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, IT CAN BE CONCLUDED THAT THERE WAS NO FAILURE AND MALFUNCTION IN THE DEVICE. HEAVY SALIVATION AND SWALLOWING THE GEL MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE INVESTIGATION RESULTS, NO PRODUCT FAILURE AND OUT OF SPECIFICATION WAS FOUND AND NO CORRECTIVE ACTION IS NEEDED. DFU IS ADEQUATE AND IT DESCRIBES FIRST AID INSTRUCTIONS IF GEL IS SWALLOWED, PROPER ISOLATION STEPS, CANDIDATE QUALIFICATION, WARNINGS, INGREDIENTS, AND OTHER PRECAUTIONS. PRODUCT WAS USED UP DURING THE PROCEDURE.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2017 IN WHICH DENTAL HYGIENIST REPORTED THAT AFTER IN-OFFICE TEETH WHITENING PROCEDURE, PATIENT FELT NAUSEOUS AND WENT TO HOSPITAL AFTER VOMITING BLOOD. THE PATIENT ALSO EXPERIENCED BURNING ON TONGUE AND ROOF OF THE MOUTH. THE DENTAL ASSISTANT STATED THAT THE PATIENT SWALLOWED THE GEL AND HAD A LOT OF SALIVATION DURING THE WHITENING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785557 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT EEG DISCUS DENTAL, LLC 881055701540 17243005 00075020035004

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization