BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK SGS

    MDR report key: 19833949 · Received July 25, 2024

    Report

    Report Number
    1422375-2024-00019
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 25, 2024
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NSK AMERICA RECEIVED A REPORT FROM OUR DISTRIBUTOR THAT AN SGS-E2S HANDPIECE OVERHEATED DURING A TOOTH EXTRACTION PROCEDURE AND THE PATIENT RECEIVED A BURN TO THEIR LIP. PATIENT INFORMATION OR STATUS HAS NOT BEEN PROVIDED AT THE TIME OF THIS REPORT AND A FOLLOW-UP REPORT WILL BE MADE IF FURTHER INFORMATION ABOUT THE EVENT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922312 NSK SGS DENTAL HANDPIECE KMW NAKANISHI INC. SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other