BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ART-E1 ELECTROSURGERY UNIT

    MDR report key: 1424020 · Received July 21, 2009

    Report

    Report Number
    2087307-2009-00001
    Event Type
    Injury
    Date Received
    July 21, 2009
    Date of Event
    July 11, 2007
    Report Date
    July 20, 2009
    Manufacturer
    BONART CO., LTD.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON APRIL OF 2009, WE RECEIVED A LETTER FROM THE PATIENT'S LAWYER STATING THAT THEY HAD BEEN AN INCIDENT BACK ON (B)(6) 2007 WHERE PATIENT WAS BURNED DURING A PROCEDURE BY THE DENTIST AT HIS DENTAL CLINIC WHILE USING THE HAND PIECE WITH BLADE OPTION THAT WAS BEING CLAIMED TO HAVE BEEN INCLUDED WITH THE BONART'S ART-E1 ELECTROSURGERY UNIT. BASED ON THE LETTER WE HAVE GOTTEN, WE HAVE FORWARDED ALL CLAIMS FROM THE PATIENT AND DOCTOR TO OUR PRODUCT LIABILITY INSURANCE (B)(6) TO HANDLE THE CLAIM. A MEMO INDICATING THIS INCIDENT WAS FORWARDED TO THE MANUFACTURER (BONART CO., LTD.-(B)(4)) OF THIS UNIT ON APRIL 17, 2009 FOR THEM TO DO THEIR OWN INTERNAL INVESTIGATION OF THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ART-E1 ELECTROSURGERY UNIT DENTAL ELECTROSURGICAL UNIT & ACCESS GEI BONART CO., LTD. ART-E1 DECEMBER 13, 2006

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other