BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENING LAMP AND PROCEDURE KIT 25%

    MDR report key: 2326936 · Received September 22, 2011

    Report

    Report Number
    2032714-2011-00008
    Event Type
    Other
    Date Received
    September 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    September 19, 2011
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 MANUFACTURING SPECIFICATIONS UPON SHIPMENT TO THE CUSTOMER. THE RETAIN SAMPLE OF THE CHAIR SIDE GEL USED IN THE PROCEDURE (AND IS DIRECTLY APPLIED TO THE TEETH) WAS WITHIN ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON (B)(6) 2011; HOWEVER, IT WAS FORMALLY REPORTED TO DISCUS DENTAL FROM DR. (B)(6) ON (B)(6) 2011. PRIOR TO PROCEDURE, PT WAS GIVEN/TOOK 800 MG. MOTRIN. DURING THE PROCEDURE, THE PT REQUESTED TO STOP PROCEDURE DUE TO DISCOMFORT (ZINGERS). PT LEFT OFFICE; CLAIMED SENSITIVITY (ZINGERS) CONTINUED FOR NEXT 72 HOURS. AFTER THE PROCEDURE WAS STOPPED, THE DENTIST OFFICE CALLED IN AN RX FOR 800 MG. MOTRIN/IBUPROFEN AND ADVISED TO TAKE MOTRIN EVERY 6 HOURS. PT WENT TO EMERGENCY ROOM THE SAME EVENING OF (B)(6) 2011 AND WAS PRESCRIBED HYDROMORPHONE/DILAUDID. ON (B)(6) 2011 DR. (B)(6) PROVIDED RELIEF GEL WITH ACP AND FLUORIDE GEL/TOOTHPASTE; ALL DISCUS DENTAL PRODUCTS. AS OF THE COMPLAINT DATE ((B)(6) 2011) PT CLAIMS CONSISTENT ACHING ON LOWER ARCH AND DISCOMFORT WITH COOL AIR AND COLD/HOT DRINKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING LAMP AND PROCEDURE KIT 25% EEG DISCUS DENTAL, LLC ZM2604R 11150017

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization