BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENING LAMP AND PROCEDURE KIT

    MDR report key: 2823788 · Received July 9, 2010

    Report

    Report Number
    2032714-2010-00001
    Event Type
    Other
    Date Received
    July 9, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 23, 2010
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISCUS TECHNICAL SPECIALIST FOR ZOOM CHAIRSIDE WHITENING ((B)(4)) INVESTIGATED THE INCIDENT AND EVALUATED THE PROCESS / PROCEDURES THAT THE DENTIST OFFICE USED IN WHITENING THE PTS TEETH. IT WAS STRONGLY RECOMMENDED THAT THE DFU FOR THE WHITENING PROCEDURE BE FOLLOWED; UP TO AND INCLUDING USING ALL MATERIALS PROVIDED; MOST SPECIFICALLY THE RETRACTORS. IN ADDITION, THE DENTIST STAFF HAS TO MAKE SURE THE PT REMAINS STILL DURING EACH 15 MINUTE SESSION AND THAT IF THE PT FEELS ANY DISCOMFORT AT ANY TIME, TO COMMUNICATE THAT IMMEDIATELY. THE DFU WAS REVIEWED TO MAKE SURE THAT THE DFU WAS ADEQUATE AND UNDERSTANDABLE. THE DFU WAS ALSO REVIEWED TO MAKE SURE IT CONTAINED BEST PRACTICE TECHNIQUES TO AVOID UV EXPOSURE TO LIPS AND GUMS, MANAGING PT BEHAVIOR, DENTIST/PT EXPECTATIONS AS WELL AS INITIAL AND F/U TRAINING. DEVICE #2: LOT#: 10137017; EXP DATE: NOV 2012; OTHER: (B)(4).

    Description of Event or Problem · 1

    THE PT CLAIMS AS A RESULT OF THE PROCEDURE, THAT SHE EXPERIENCED SWELLING OF THE UPPER LIP WITH A BLISTER, AS WELL AS WHITE MARKS ON THE UPPER GINGIVAL. THE PT INDICATED THE RETRACTOR USED IN THE PROCEDURE WAS YELLOW; EITHER VERSION OF A ZOOM CHAIR SIDE KIT ISN OT YELLOW; THIS COULD NOT BE CONFIRMED BY DR (B)(6). THE PT ALSO STATED DR (B)(6) DID NOT PERFORM THE PROCEDURE. THE PT ADMITTED TO PRE-MEDICATING PRIOR TO THE INCIDENT TO RELAX HERSELF; TOOK PERCOCET AND BENZAPRINE. THE PT IS A NURSE (LEVEL UNK) AND SOUGHT THE ADVICE OF A DOCTOR ON STAFF AT HER EMPLOY; IT IS NOT KNOWN IF THE DOCTOR WAS HER PCP, BUT SHE DID NOT OR WAS NOT DIRECTED TO A HOSP OR ER FACILITY. PT'S DENTIST DR (B)(6) CLAIMS THE PT WAS MOVING AND TALKING DURING THE PROCEDURE; WHICH CAN COMPROMISE THE UV ISOLATION MATERIALS FOR THE LIPS AND GUMS. DR (B)(6) DID SEE THE PT ON A F/U VISIT ON (B)(6) 2010 AND DID NOT SEE ANYTHING OUT OF THE ORDINARY. THERE WAS SOME EXPECTED SENSITIVITY OF THE TEETH, AS WELL AS A SWOLLEN UPPER LIP (BUT NO BLISTER). THE DOCTOR GAVE THE PT VITAMIN E FOR THE SWOLLEN LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING LAMP AND PROCEDURE KIT EEG DISCUS DENTAL, LLC ZM2564 09238002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization