BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 7113581 · Received December 13, 2017

    Report

    Report Number
    1000582314-2017-00011
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 13, 2017
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    UDI-DI
    00075020035004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017 IN WHICH PATIENT EXPERIENCED SWOLLEN LIPS AFTER IN-OFFICE ZOOM TEETH WHITENING PROCEDURE. PATIENT VISITED URGENT CARE AFTER THE INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED. INVESTIGATION: - THE RETAIN SAMPLE OF THE IN-OFFICE WHITENING GEL, SKU: 22-3764, LOT: 17297005 WAS TESTED ON (B)(6) 2017 AND RESULTS WERE WITHIN SPECIFICATIONS. - REVIEWED DEVICE HISTORY RECORDS OF ZOOM WHITENING KIT, SKU: 881055701540, LOT: 17299012, AND WHITENING GEL, SKU: 22-3764, LOT: 17297005 AND NO OUT OF SPECIFICATION OR DISCREPANCY WAS FOUND IN THE RECORDS. - REVIEWED COMPLAINTS HISTORY, NO OTHER SIMILAR INCIDENTS WERE REPORTED WITH THE SAME LOT NUMBERS. - BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, IT CAN BE CONCLUDED THAT THERE WAS NO FAILURE AND MALFUNCTION IN THE DEVICE. POTENTIAL CAUSES MAY BE IMPROPER LIPS ISOLATION PRIOR TO THE PROCEDURE OR IMPROPER ALIGNMENT OF THE LAMP WITH THE LIP RETRACTOR. ZOOM IN-OFFICE DFU IS ADEQUATE AND IT DESCRIBES THE WARNINGS AND PRECAUTIONS AND STEPS FOR PROPER LIP ISOLATION AND ALIGNMENT OF THE LAMP WITH THE RETRACTOR. BASED ON THE INVESTIGATION RESULTS, NO PRODUCT FAILURE AND OUT OF SPECIFICATION WAS FOUND. DFU IS ADEQUATE AND NO CORRECTIVE ACTION IS NEEDED. 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 EXPERIENCED SWOLLEN LIPS AFTER IN-OFFICE ZOOM TEETH WHITENING PROCEDURE. PATIENT VISITED URGENT CARE AFTER THE INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895312 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT EEG DISCUS DENTAL, LLC 881055701540 17299012 00075020035004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other