BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 5676525 · Received May 24, 2016

    Report

    Report Number
    1000582314-2016-00004
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    April 28, 2016
    Report Date
    May 24, 2016
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2016, IN WHICH PATIENT EXPERIENCED SENSITIVITY AND PAIN DURING A ZOOM TEETH WHITENING PROCEDURE. THE DENTIST PRESCRIBED MOTRIN AND VICODIN TO RELIEVE THE PAIN. AFTER RECEIVING THIS REPORT, RETAIN SAMPLE OF WHITENING GEL, LOT: 15168013, WAS TESTED AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE GEL AND KIT WERE USED DURING THE PROCEDURE, AND WERE NOT RETURNED. DEVICE HISTORY RECORD OF WHITENING GEL SKU: 22-3764, LOT: 15168013 AND WHITENING KIT SKU: ZM2666 LOT: 15189003 WERE ALSO REVIEWED, AND NO OUT OF SPECIFICATIONS OR DISCREPANCY WAS FOUND. REVIEWED COMPLAINT HISTORY. NO OTHER SIMILAR COMPLAINTS WERE RECEIVED WITH THE SAME LOT NUMBERS. DURING INVESTIGATION, IT WAS FOUND THAT THE DENTAL OFFICE DID NOT MAKE A TRAY FOR THE PATIENT PRIOR TO THE PROCEDURE AS DESCRIBED IN DFU. TRAYS WITH RELIEF ACP CAN TREAT SENSITIVITY AND PAIN. DFU IS ADEQUATE. PRE-TREATMENT AND POST TREATMENT FOR SENSITIVITY RELIEF ARE DESCRIBED IN DFU. NO CORRECTIVE ACTION IS REQUIRED. DISCUS DENTAL WILL CONTINUE TO MONITOR THE TREND OF SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2016, IN WHICH PATIENT EXPERIENCED SENSITIVITY AND PAIN AFTER THE FIRST SESSION OF A TEETH WHITENING PROCEDURE. THE DENTIST PRESCRIBED MOTRIN AND VICODIN TO RELIEVE THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330646 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT AND GEL EEG DISCUS DENTAL, LLC 22-3764 15168013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other