BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS ZOOM

    MDR report key: 6324494 · Received February 10, 2017

    Report

    Report Number
    1000582314-2017-00002
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 10, 2017
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RECEIVED A COMPLAINT ON 01/13/2017, WHERE PATIENT EXPERIENCED SENSITIVITY AND PAIN DURING ZOOM CHAIRSIDE IN-OFFICE TEETH WHITENING PROCEDURE. THE PATIENT TOOK VICODIN, HOWEVER IT WAS NOT PRESCRIBED BY THE DENTIST. THE PATIENT DID NOT VISIT A MEDICAL FACILITY, AND IS FEELING BETTER NOW. INVESTIGATION AFTER RECEIVING THIS REPORT, RETAIN SAMPLE OF THE WHITENING GEL FROM THE SAME LOT (LOT# 16183030), WAS TESTED AND THE RESULTS WERE WITHIN SPECIFICATIONS; THE GEL AND KIT WERE USED DURING THE PROCEDURE, AND WERE NOT RETURNED; DEVICE HISTORY RECORDS OF WHITENING GEL SKU: 22-3764, LOT: 16183030; WHITENING KIT SKU: ZM2665, LOT: 16161012; AND WHITENING LAMP SKU: ZM3000, SERIAL NUMBER: (B)(4) WERE REVIEWED, AND NO OUT OF SPECIFICATIONS OR DISCREPANCY WAS FOUND IN THE RECORDS; REVIEWED COMPLAINTS HISTORY. NO OTHER SIMILAR COMPLAINTS WERE RECEIVED WITH THE SAME LOT NUMBERS; REVIEWED INSTRUCTIONS FOR USE OF THE WHITENING KIT. IT DESCRIBES CANDIDATE QUALIFICATIONS, STEP-BY-STEP PROCEDURE, PRECAUTIONS, WARNINGS, AND PRE-TREATMENT AND POST TREATMENT FOR SENSITIVITY. CONCLUSION: NO DEVICE FAILURE OR OUT OF SPECIFICATION WAS FOUND DURING THE INVESTIGATION. IT CAN BE CONCLUDED THAT PRE-EXISTING SENSITIVITY OR FAILURE TO FOLLOW PRE-PROCEDURE STEPS DESCRIBED IN DFU CONTRIBUTED TO THIS EXPERIENCE. DFU IS ADEQUATE, AND NO CORRECTIVE ACTION IS REQUIRED. (B)(4) WILL CONTINUE TO MONITOR THE TREND OF SIMILAR COMPLAINTS. THE WHITENING KIT AND GEL WERE USED.

    Description of Event or Problem · 1

    (B)(4) RECEIVED A COMPLAINT ON 01/13/2017, WHERE PATIENT EXPERIENCED SENSITIVITY AND PAIN DURING ZOOM CHAIRSIDE IN-OFFICE TEETH WHITENING PROCEDURE. THE PATIENT TOOK VICODIN, HOWEVER IT WAS NOT PRESCRIBED BY THE DENTIST. THE PATIENT DID NOT VISIT A MEDICAL FACILITY, AND IS FEELING BETTER NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105436 PHILIPS ZOOM ZOOM CHAIRSIDE WHITENING KIT AND GEL EEG DISCUS DENTAL, LLC ZM2665 16161012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other