BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLARA

    MDR report key: 14571265 · Received June 2, 2022

    Report

    Report Number
    9611253-2022-00035
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 2, 2022
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    PMA / PMN Number
    K962543
    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 SOLARA-03 (GRW) 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 ((B)(4)) ABOUT A PATIENT'S ACCIDENTAL INGESTION OF A DENTAL BUR. DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2022. THE DENTIST WAS PERFORMING A FILLING PROCEDURE ON A PATIENT USING A TURBINE HANDPIECE WITH A BUILT-IN NSK CARTRIDGE (SERIAL NO. (B)(4)). THE PATIENT WAS UNDER LOCAL ANESTHESIA. DURING THE PROCEDURE, THE BUR FELL IN THE PATIENT'S MOUTH, AND THE PATIENT ACCIDENTALLY SWALLOWED THE BUR. THE PATIENT RETURNED TO THE DENTAL OFFICE 2 WEEKS AFTER THE INCIDENT, AND REPORTED THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413481 SOLARA HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. SOLARA-03 (GRW)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other