BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIC XT

    MDR report key: 1397322 · Received June 2, 2009

    Report

    Report Number
    1032227-2009-00015
    Event Type
    Other
    Date Received
    June 2, 2009
    Date of Event
    June 2, 2008
    Report Date
    December 10, 2008
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EBW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING CONVERSATION IN (B) (6) 2008, DENTIST NOTED INCIDENT OCCURRING IN (B) (6) 2008 AS FOLLOWS: DENTIST NOTED DURING EXTRACTION OF WISDOM TEETH, PT HAD A "HANDPIECE SHAPED BURN ON LIP." DENTIST NOTED BURN ON LOWER LIP AND DENTIST PUT SUTURES ON PT. PT RETURNED FOR FOLLOW UP ON (B) (6) 2008. DENTIST WAS UNABLE TO PROVIDE SERIAL NUMBER OF UNIT USED, JUST MAKE AND MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIC XT EBW NSK TOCHIGI-KEN SGA-E

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other