BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 6231372 · Received January 6, 2017

    Report

    Report Number
    1000582314-2017-00001
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    August 30, 2016
    Report Date
    January 6, 2016
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL RECEIVED A COMPLAINT ON 12/08/2016, IN WHICH THE PATIENT STATED SHE IS STILL EXPERIENCING PAIN AFTER AN IN-OFFICE ZOOM TEETH WHITENING PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED BURN ON TOP GUMS DURING THE WHITENING PROCEDURE. THE PATIENT VISITED EAR, NOSE AND THROAT DOCTOR, HOWEVER SHE ONLY TOOK OTC DRUG FOR THE PAIN. NO INFORMATION WAS PROVIDED BY THE PATIENT REGARDING PRODUCT PART NUMBER, LOT NUMBER, OR DENTAL OFFICE CONTACT INFORMATION. DURING THE FOLLOW UP WITH THE PATIENT ON 12/20/2016, PATIENT STATED THAT THE PAIN HAS GOTTEN BETTER. NO FURTHER INFORMATION. - REVIEWED DIRECTION FOR USE OF THE IN-OFFICE WHITENING ZOOM CHAIRSIDE KIT. IT DESCRIBES THE STEPS FOR PROPER ISOLATION OF SOFT TISSUE TO PREVENT BURN AND IRRITATION. IT ALSO INCLUDES CANDIDATE QUALIFICATION, SAFETY DIRECTIONS, WARNINGS, AND PRECAUTIONS. - REVIEWED COMPLAINTS HISTORY OF THE PAST YEAR. ONLY ONE OTHER SIMILAR INCIDENT WAS REPORTED IN THE UNITED STATES, IN WHICH THE USER FAILED TO PROPERLY PERFORM THE ISOLATION PRIOR TO THE PROCEDURE. (REPORT # 1000582314-2016-00007). WITH THE AVAILABLE INFORMATION, DISCUS DENTAL CONCLUDES THERE WAS NO MALFUNCTION OR FAILURE IN THE PRODUCT. NO CORRECTIVE ACTIONS ARE REQUIRED. THE POTENTIAL CAUSE OF THIS INCIDENT CAN BE FAILURE TO FOLLOW THE INSTRUCTIONS PROVIDED WITH THE PRODUCT. ANY PRE-EXISTING MEDICAL CONDITION OF THE PATIENT MAY ALSO HAVE CONTRIBUTED TO THIS ADVERSE EVENT. 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 12/08/2016, IN WHICH THE PATIENT STATED SHE IS STILL EXPERIENCING PAIN AFTER AN IN-OFFICE ZOOM TEETH WHITENING PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED BURN ON TOP GUMS DURING THE WHITENING PROCEDURE. THE PATIENT VISITED EAR, NOSE AND THROAT DOCTOR, HOWEVER SHE ONLY TOOK ADVIL FOR THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11304 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT AND GEL EEG DISCUS DENTAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other