BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 7368731 · Received March 24, 2018

    Report

    Report Number
    9611253-2018-00012
    Event Type
    Injury
    Date Received
    March 24, 2018
    Date of Event
    February 23, 2018
    Report Date
    March 22, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016004. (B)(4). NAM TOOK THE FOLLOWING ACTIONS TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT INCLUDING THE PATIENT, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. AFTER THE COMMUNICATION WITH THE DENTAL ASSISTANT ON (B)(6), NAM FORWARDED THE INFORMATION REQUEST FORMS, (B)(4) AND (B)(4) TO THE OFFICE BY E-MAIL. NO INFORMATION WAS PROVIDED. ON (B)(6) 2018, NAM CONTACTED THE ASSISTANT BY E-MAIL, BUT NO RESPONSE WAS RECEIVED. ON (B)(6) 2018, NAM SENT AN E-MAIL TO THE ASSISTANT REQUESTING TO FORWARD ALL 7 HANDPIECES TO NAM TO AVOID A POSSIBLE EVENT FROM OCCURRING. NO RESPONSE WAS RECEIVED FROM THE DENTAL OFFICE. ON (B)(6) 2018, NAM CONTACTED THE ASSISTANT BY E-MAIL AND VOICE MAIL MESSAGE TO REQUEST INFORMATION ON THE DEVICE(S) AND THE PATIENT. NO RESPONSE WAS PROVIDED. ON (B)(6) 2018, NAM MADE A CALL TO THE FACILITY REQUESTING IDENTIFICATION OF THE DEVICE MODEL NUMBER AND/OR SERIAL NUMBER OF THE DEVICE(S). THE ASSISTANT NOR THE DENTIST WAS AVAILABLE. NO RESPONSE WAS RECEIVED. ON (B)(6) 2018, NAM MADE A PHONE CALL AND LEFT A MESSAGE FOR THE ASSISTANT OR THE DENTIST TO CONTACT NAM. NO REPLY WAS RECEIVED. ON (B)(6) 2018, NAM CONTACTED THE ASSISTANT BY EMAIL AND VOICE MAIL REQUESTING INFORMATION OF THE DEVICE(S) AND PATIENT. NO INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ON (B)(6) 2018, (B)(4) RECEIVED AN E-MAIL FROM A DISTRIBUTOR (B)(4) ABOUT A PROBLEM WITH AN (B)(4) DENTAL PRODUCT. ON (B)(6) 2018, (B)(4) WAS MADE AWARE BY A PHONE CALL FROM A DENTAL ASSISTANT THAT A DENTAL BUR HAD COME OUT OF AN (B)(4) HANDPIECE AND A PATIENT HAD SWALLOWED THE BUR. THE EVENT OCCURRED ON (B)(6) 2018. THE DENTIST WAS PERFORMING A DENTAL PROCEDURE USING THE HANDPIECE WITH THE BUR. DURING THE PROCEDURE, THE BUR CAME OUT OF THE HANDPIECE AND THE PATIENT SWALLOWED THE BUR. ACCORDING TO THE DENTAL ASSISTANT, THE PATIENT WAS NOT INJURED IN THE EVENT. THE DENTIST COULD NOT IDENTIFY THE HANDPIECE INVOLVED IN THE EVENT, BECAUSE THE OFFICE HAS 7 HANDPIECES AND THE SUBJECT DEVICE WAS ADDED BACK INTO THE PRODUCTION ROTATION OF 7 AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211553 NSK UNKNOWN EFB NAKANISHI INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other