BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SGS-E2S

    MDR report key: 18871527 · Received March 8, 2024

    Report

    Report Number
    1422375-2024-00007
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    January 16, 2024
    Report Date
    March 8, 2024
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    DURING A SURGICAL THIRD MOLAR EXTRACTION PROCEDURE THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A SECOND DEGREE BURN TO THEIR LIP. PATIENT WAS TREATED FOR THE BURN INJURY IN THE ER AT THE TIME OF THE INCIDENT AND WAS RECOMMENDED TO FOLLOW UP WITH THE BURN CENTER IF NECESSARY. THE END-USER HAS NOT BEEN MADE AWARE OF THE NEED FOR ADDITIONAL MEDICAL TREATMENT OR COMPLICATIONS FROM THE INJURY SINCE THE INCIDENT.THE END-USER WAS NOT ABLE TO IDENTIFY THE HANDPIECE SERIAL NUMBER INVOLVED IN THE INCIDENT BUT IS ONE OF THREE THEY HAVE AT THE LOCATION. SINCE THE SPECIFIC HANDPIECE SERIAL NUMBER CANNOT BE IDENTIFIED, THREE REPORTS WILL BE MADE. [THIS IS REPORT 2 OF 3, PLEASE SEE MDR 2024-00006, 2024-00008 FOR SPECIFIC DEVICE INFORMATION].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695289 SGS-E2S DENTAL HANDPIECE KMW NAKANISHI INC. SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other