BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIC XT

    MDR report key: 1848899 · Received September 24, 2010

    Report

    Report Number
    1032227-2010-00019
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    NSK TOCHIGI-KEN
    Product Code
    EBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL OFFICE ADVISED THAT DURING A SURGICAL PROCEDURE ON LOWER RIGHT, THE TIP OF THE SURGICAL ATTACHMENT HEATED UP, THE PATIENT NOTICED AND THE TREATMENT STOPPED. DENTIST NOTED A BLISTER THE SIZE OF THE TIP (SMALL) AND TREATED WITH ANTIBIOTIC CREAM. SCHEDULED FOLLOW UP WITH PATIENT FOR THE NEXT WEEK. INSTRUCTIONS WERE GIVEN TO THE PATIENT ON HOW TO TAKE CARE OF THE BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIC XT EBW NSK TOCHIGI-KEN H185001 SGS E2G

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other