BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 6123486 · Received November 22, 2016

    Report

    Report Number
    1000582314-2016-00008
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    June 1, 2016
    Report Date
    November 22, 2016
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 10/25/2016. THE PATIENT COMPLETED IN-OFFICE TEETH WHITENING PROCEDURE, AND SINCE THEN SHE IS EXPERIENCING TOOTH LINGERING SENSITIVITY. THE PATIENT VISITED A SPECIALIST FOR EVALUATION, WHO FOUND NOTHING WRONG. AFTER RECEIVING THIS REPORT, RETAIN SAMPLE OF THE WHITENING GEL, LOT: 15232022, WAS TESTED AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE GEL AND KIT WERE USED DURING THE PROCEDURE, AND WERE NOT RETURNED. BATCH HISTORY RECORD OF WHITENING GEL SKU: 22-3764, LOT: 15232022 WAS REVIEWED, AND NO OUT OF SPECIFICATIONS, NON-CONFORMANCE OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINT HISTORY. NO OTHER COMPLAINTS WERE RECEIVED WITH THE SAME LOT NUMBER. BASED ON THE INVESTIGATION RESULTS, NO PRODUCT FAILURE OR MALFUNCTION WAS DETECTED. DENTAL OFFICE INFORMED THAT THE PATIENT HAD SCALING AND ROOT PLANNING (SRP) ONE MONTH BEFORE THE WHITENING PROCEDURE. WITH THE AVAILABLE INFORMATION, IT CAN BE CONCLUDED THAT, PRE-EXISTING SENSITIVITY MAY HAVE CONTRIBUTED TO THE LINGERING TEETH SENSITIVITY. IT IS ALSO PLAUSIBLE THAT SCALING AND ROOT PLANNING PRIOR TO THE WHITENING MIGHT HAVE ENHANCED THE SENSITIVITY EXPERIENCE. DFU IS ADEQUATE. PRE-TREATMENT AND POST TREATMENT FOR SENSITIVITY ARE DESCRIBED IN DFU. NO CORRECTIVE ACTION IS REQUIRED. IT ALSO INCLUDES WARNINGS, PRECAUTIONS, AND CANDIDATE QUALIFICATION. DISCUS DENTAL WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS. THE WHITENING KIT AND GEL WERE USED.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 10/25/2016. THE PATIENT COMPLETED IN-OFFICE TEETH WHITENING PROCEDURE, AND SINCE THEN, SHE IS EXPERIENCING TOOTH LINGERING SENSITIVITY. THE PATIENT VISITED A SPECIALIST FOR EVALUATION, WHO FOUND NOTHING WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773851 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT AND GEL EEG DISCUS DENTAL, LLC 22-3764 15232022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other