BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTORQUE LITE 1:5 FRICTION GRIP ATTACHMENT W/AC

    MDR report key: 15459883 · Received September 20, 2022

    Report

    Report Number
    9611253-2022-00064
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 21, 2022
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, NAKANISHI RECEIVED AN EMAIL FROM THE DISTRIBUTOR STATING THAT THE DISTRIBUTOR HAD NO INTENTION OF RETURNING THE DEVICE INVOLVED IN THE EVENT OR DISCLOSING ANY FURTHER INFORMATION, INCLUDING INFORMATION ABOUT THE PATIENT. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI EXAMINED THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT X95L STD DEVICE SERIAL NO. (B)(4). AS A RESULT OF THE EXAMINATION, NAKANISHI FOUND THAT THE DHR INDICATED THAN NO PROBLEMS OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, NAKANISHI RECEIVED A LETTER FROM A DISTRIBUTOR (DENTALEZ INC.) ABOUT A PATIENT'S BURN INJURY. DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2022. THE DENTIST WAS PERFORMING A CROWN PREPARATION ON TOOTH #5 OF A PATIENT USING THE X95L STD HANDPIECE (SERIAL NO. (B)(4). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A BURN INJURY. THE DENTIST BECAME AWARE OF A BLISTER ON THE INSIDE OF THE PATIENT'S LIP WHEN THE PATIENT JUMPED AND STATED THAT IT FELT HOT. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534376 NUTORQUE LITE 1:5 FRICTION GRIP ATTACHMENT W/AC HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. X95L STD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other