BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK SGS

    MDR report key: 18999008 · Received March 28, 2024

    Report

    Report Number
    1422375-2024-00009
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 7, 2024
    Report Date
    March 28, 2024
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    UDI-DI
    04560264556294
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DOCTOR WAS CUTTING A WISDOM TOOTH WHEN THE ATTACHMENT LOCKED UP AND THE PATIENT RECEIVED A BURN INJURY TO THEIR TONGUE. NO MEDICAL TREATMENT WAS REQUIRED AT THE TIME OF THE INCIDENT. THE PATIENT HAS NOT HAD A FOLLOW-UP VISIT WITH THE DOCTOR AT THIS TIME AND THE DOCTOR HAS NOT RECEIVED ANY REPORT OF COMPLICATIONS OR THE NEED FOR FURTHER MEDICAL TREATMENT FROM THE PATIENT AS A RESULT OF THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985608 NSK SGS DENTAL HANDPIECE KMW NAKANISHI INC. SGS-E2S 04560264556294

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Other