BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLARA

    MDR report key: 12921766 · Received December 2, 2021

    Report

    Report Number
    9611253-2021-00068
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    October 28, 2021
    Report Date
    December 3, 2021
    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 DECEMBER 1, 2021, 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 THAT NO PROBLEMS OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.

    Description of Event or Problem · 0

    ON NOVEMBER 9, 2021, 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) 2021. THE DENTIST WAS CUTTING #14 OF THE PATIENT'S TEETH USING A TURBINE HANDPIECE WITH A BUILT-IN NSK CARTRIDGE. (SERIAL NO.: (B)(4)). DURING THE PROCEDURE, THE BUR FELL IN THE PATIENT'S MOUTH AND THE PATIENT ACCIDENTALLY SWALLOWED THE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817512 SOLARA HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. SOLARA-03 (GRW)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other