BEUDAMED
    FDA Adverse Event Summary report: N

    FLASH LITE MAGNA

    MDR report key: 3830481 · Received May 23, 2014

    Report

    Report Number
    1000582314-2014-00003
    Date Received
    May 23, 2014
    Date of Event
    January 26, 2012
    Report Date
    March 10, 2014
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EBZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME THE ADVERSE EVENT WAS REPORTED TO DISCUS DENTAL LLC ON (B)(6) 2014, DISCUS DENTAL NO LONGER MANUFACTURE THE MEDICAL DEVICE. THE MEDICAL DEVICE, FLASHLITE MAGNA WAS DIVESTED TO DENMAT IN JUNE 2012. ALL DEVICE HISTORY RECORDS WERE ALSO GIVEN TO DENMAT AS PART OF THE DIVESTURE. DISCUS DENTAL HAVE CONTACTED DENMAT FOR A COPY OF THE DEVICE HISTORY RECORD FOR THE MEDICAL DEVICE EVALUATION BUT DENMAT HAS NOT RESPONDED AS OF 03/10/2014.

    Description of Event or Problem · 1

    (B)(6) STATED THAT AFTER HAVING A ROUTINE DENTAL PROCEDURE, SHE HAD SWOLLEN LIPS AND BLISTER CAUSED BY A DENTAL CURING LIGHT. (B)(6) WAS TAKEN TO THE EMERGENCY ROOM AND GIVEN MOTRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308859 FLASH LITE MAGNA DENTAL CURLING LIGHT EBZ DISCUS DENTAL, LLC MAGNA 11353040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other