BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK SGS

    MDR report key: 17148750 · Received June 16, 2023

    Report

    Report Number
    1422375-2023-00015
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 16, 2023
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE HANDPIECE TIP OVERHEATED DURING USE IN A WISDOM TOOTH EXTRACTION PROCEDURE AND THE PATIENT RECEIVED A BURN TO THE INSIDE AND OUTSIDE OF THEIR LIP ON THE LEFT SIDE. THE PATIENT'S INJURY IS REPORTED TO BE HEALING NORMALLY WITHOUT NEED OF ANY ADDITIONAL MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463337 NSK SGS DENTAL HANDPIECE KMW NAKANISHI INC. SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other