BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENING LAMP & PROCEDURE KIT

    MDR report key: 1221815 · Received October 30, 2008

    Report

    Report Number
    2032714-2008-00002
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    February 7, 2008
    Report Date
    July 24, 2008
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DISCUS DENTAL HAS TAKEN SERIES OF MEASURES TO INVESTIGATE IF THE DEVICE (LAMP OR WHITENING GEL) WAS RESPONSIBLE FOR THE INCIDENT OR IMPROPER USE OF DEVICE BY THE DENTIST WAS THE PROBABLE CAUSE OR IF THIS WAS JUST SENSITIVITY OF THE PT TO THE WHITENING PROCEDURE. THE RESULT OF THE INVESTIGATION DID INDICATE THAT EITHER THE PT WAS SENSITIVE TO THE WHITENING GEL OR THAT THE PT WAS NOT PROPERLY ISOLATED BY THE DENTIST DURING THE PROCEDURE. FURTHER INVESTIGATION DID REVEAL THAT THE DENTIST OR HIS STAFF MEMBERS HAD NOT UNDERGONE THE DISCUS DENTAL FREE DISTANCE TRAINING PROGRAM (DTP) OR THE ON-LINE TRAINING PROGRAM. A DISCUSSION WAS HAD WITH THE DENTIST ON THE NEED AND IMPORTANCE OF TRAINING AND PROPER PT ISOLATION BEFORE THE PROCEDURE. THE DENTIST WAS ALSO REMINDED THAT IT WAS THE DENTIST'S RESPONSIBILITY ONCE HE HAS BEEN TRAINED ON THE WHITENING PROCEDURE TO ENSURE THAT HIS STAFF ARE PROPERLY TRAINED IN ORDER TO AVOID INCIDENTS LIKE THIS ONE. THE DENTIST SINCE AFTER THE INCIDENT HAS COMPLETED TRAINING ON THE USE OF THE ZOOM WHITENING PROCEDURE. ALSO A PART OF THE CORRECTIVE AND PREVENTIVE ACTION FOR THIS AND SIMILAR CASES OF DENTISTS NOT COMPLETING THE ZOOM TRAINING BEFORE EMBARKING ON THE PROCEDURE, DISCUS DENTAL HAS CHANGED ITS POLICY. THE KITS AND LAMP WILL NOW ONLY BE SENT OUT TO DENTISTS WHO CAN SHOW PROOF OF TRAINING. AS PART OF THE TRAINING, WE INFORM THE DENTISTS THAT IT IS THEIR RESPONSIBILITY TO MONITOR THE PERFORMANCE OF THEIR STAFF IN ORDER TO DETERMINE WHEN RE-TRAINING IS NECESSARY. DISCUS DENTAL AS POLICY WILL REQUEST THAT A DENTIST OR A CLINIC WHICH BURNS TWO OR MORE PTS WITHIN 6 MONTHS BE RE-TRAINED ON THE ZOOM WHITENING PROCEDURE OR THOSE DENTIST WHO HAVE NOT USED THEIR WHITENING LAMPS FOR MORE THAN 6 MONTHS AFTER THE INITIAL TRAINING BE RE-TRAINED.

    Description of Event or Problem · 1

    AS REPORTED BY AN EMPLOYEE, PT HAD A ZOOM PROCEDURE IN 2008. THERE WERE NO PRE-EXISTING CONDITIONS; NO ALLERGIES TO REPORT. PT MEDICATIONS (THAT WERE BEING TAKEN) ALLEGRA, AMBIEN AND CLOMID. PT CALLED LATE AFTERNOON, STATED LIP WAS SWOLLEN, SHE WENT TO THE DOCTOR'S OFFICE AND WAS PRESCRIBED DEXAMETHASONE ACETATE AND KENALOG-40 PER 10MG. SHE LATER WENT TO THE EMERGENCY ROOM AND WAS ADMINISTERED AN IV (THE OFFICE WAS NOT INFORMED ABOUT CONTENT OF THE IV).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING LAMP & PROCEDURE KIT EEG DISCUS DENTAL, LLC ZM2604 07358115

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization