BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SGS

    MDR report key: 20592009 · Received November 1, 2024

    Report

    Report Number
    1422375-2024-00028
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 1, 2024
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE HANDPIECE OVERHEATED DURING A TOOTH EXTRACTION PROCEDURE AND THE PATIENT RECEIVED A BURN TO THEIR LIP. THE PATIENT IS REPORTED TO HAVE HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188692 SGS DENTAL HANDPIECE KMW NAKANISHI INC. SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other