BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLTOLUX 3 CURING LIGHT

    MDR report key: 193645 · Received October 23, 1998

    Report

    Report Number
    2416455-1998-00001
    Event Type
    Other
    Date Received
    October 23, 1998
    Date of Event
    July 18, 1998
    Report Date
    October 22, 1998
    Manufacturer
    COLTENE/WHALEDENT, INC.
    Product Code
    EBZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT'S FACE BURNED/SCARRED FROM CURING LIGHT. PER PT, DR CLAIMS MALFUNCTION OF EQUIPMENT AND REFERRED TO C/W AS MFR; PT INTENDS TO FILE CLAIM/PURSUE ACTION AND IS GOING THRU PROPER CHANNELS ALTHOUGH SHE SUSPECTS MISUSE BY THE ASSISTANT PER TELECON W/PT. 5 FILLINGS BEING DONE IN ONE DAY; WAS NUMB TOP TO BOTTOM. DR AND ASSISTANT ON EACH SIDE OF CHAIR; WHILE WORKING ON UPPER LEFT MOLAR, ASSISTANT RESTED GUN ON PT'S FACE WHILE REACHING/WORKING ACROSS; BURNED LEFT CORNER OF MOUTH/FACE. PT RETURNED TO OFFICE SAME DAY TO SHOW BLISTERING; DR'S OFFICE/ASSISTANT WAS VERY APOLOGETIC USING PHRASES SUCH AS: "NEVER HAPPENED BEFORE", "IS NO MUCH MORE CAREFUL" WHEN CURING/WORKING WITH LITE: "NOW PUTS FINGERS BETWEEN GUN AND PT'S MOUTH/FACE." CLAIMS ASSISTANT WAS AWARE OF AND FELT HEAT OF GUN (ASSUME LITE GUIDE) AFTER THE PROCEDURE. DR'S OFFICE PROVIDED LETTER WITH MODEL/SERIAL NUMBER AND SUGGESTING EQUIPMENT DEFECT; INDICATING C/W. DR'S OFFICE HAS BEEN CALLED ON 9/16, AND WORD HAS BEEN LEFT. WORD HAS BEEN LEFT ON PT'S VOICE MAIL ON 9/16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLTOLUX 3 CURING LIGHT CURING LIGHT FOR CURING COMPOSITES EBZ COLTENE/WHALEDENT, INC. C7910 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other