BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SGS

    MDR report key: 22613621 · Received July 25, 2025

    Report

    Report Number
    1422375-2025-00013
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 25, 2025
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    UDI-DI
    04560264556294
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE HANDPIECE OVERHEATED ABNORMALLY DURING A THIRD MOLAR EXTRACTION PROCEDURE AND THE PATIENT RECEIVED A THERMAL BURN TO THEIR EXTERNAL CHEEK. THE BURN OCCURRED WHEN THE DOCTOR RESTED THE HANDPIECE ON THE PATIENT'S CHEEK DURING THE PROCEDURE, NOT REALIZING THAT IT HAD BECOME VERY HOT WHILE IN USE. THE PATIENT WAS REFERRED TO A DERMATOLOGIST FOR FURTHER TREATMENT OF THE INJURY AND IS EXPECTED TO HEAL NORMALLY WITH LITTLE TO NO SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939707 SGS DENTAL HANDPIECE KMW NAKANISHI INC. SGS-E2S 04560264556294

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Other