BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENING LAMP AND PROCEDURE KIT

    MDR report key: 2216387 · Received July 28, 2011

    Report

    Report Number
    2032714-2011-00002
    Event Type
    Other
    Date Received
    July 28, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 20, 2011
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED THE DHR FOR THE ZOOM WHITENING SYSTEM. THE LAMP USED IN THE PROCEDURE WAS WITHIN THE MFG SPECIFICATIONS UPON SHIPMENT TO THE CUSTOMER. THE RETAIN SAMPLE OF THE CHAIR SIDE GEL USED IN THE PROCEDURE (AND GOES DIRECTLY ON THE TEETH) WAS WITHIN ALL MFG SPECIFICATIONS. THE MFG WORK ORDER FOR THE WAS REVIEWED AS WELL AND NO ABNORMALITIES FOUND IN THE PRODUCTION RUN OF THE GEL LOT NUMBER IN QUESTION. IN ADDITION AN ONLINE REPORT WAS SUBMITTED ON (B)(4) 2011 IN ERROR. THE ONLY PROOF A REPORT WAS SUBMITTED IS ATTACHED. FDA INVESTIGATOR REQUESTED THAT AN ADD'L REPORT BE SUBMITTED IN THIS FORMAT AND CERTIFIED MAIL TO MEDWATCH.

    Description of Event or Problem · 1

    PT SAID THAT HE WAS FEELING ZINGERS (TOOTH SENSITIVITY) DURING THE 3RD OF 4 CYCLES. WANTED TO CONTINUE ON TO 4TH CYCLE. AFTER THE 4TH CYCLE HE CONTINUED TO HAVE SENSITIVITY ISSUES. DR. PRESCRIBED THE PT VICODINE. HYGIENIST REPORTED THE PT DID NOT PARTICIPATE IN THE SENSITIVITY PROTOCOL WHICH SUGGESTS TO BRUSH WITH A FLUORIDE TOOTHPASTE TWO WEEKS IN ADVANCE OF A CHAIR SIDE WHITENING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING LAMP AND PROCEDURE KIT EEG DISCUS DENTAL, LLC ZM2564 10321018

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other THE PT WAS PRESCRIBED VICODIN DAY OF OCCURRENCE.