BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 4003224 · Received July 29, 2014

    Report

    Report Number
    1422375-2014-00006
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    November 20, 2013
    Report Date
    July 31, 2014
    Manufacturer
    NAKANISHI INC
    Product Code
    KMW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL NSK AMERICA INVESTIGATION: HANDPIECE SERIAL NUMBER WAS NOT PROVIDED BY THE DENTIST AND THE SUSPECT DENTAL HANDPIECE WAS NOT RETURNED TO NSK AMERICA. NSK AMERICA DOES NOT SELL FINISHED DEVICES DIRECTLY TO AN END USER (E.G. DENTIST). THEREFORE NO FURTHER RECORD SEARCHES COULD BE PERFORMED TO DETERMINE DATE OF SALE. REVIEW OF NSK AMERICAN INTERNAL SERVICE RECORDS INDICATES NO OTHER COMPLAINTS OR SERVICE REQUESTS FROM THIS DENTIST AND THE DENTAL OFFICE. NSK AMERICA CALLED THE DENTIST ON (B)(4) 2014, LEAVING A MESSAGE FOR THE DENTIST TO CONTACT NSK AMERICA, WITH NO RESPONSE AS OF THIS FILING. THE THIRD PARTY SERVICER IS UNK AT THIS TIME. NSK AMERICA HAS SENT A REQUEST FOR ADDITIONAL INFO FROM THE DENTIST ON B)(4) 2014 BY US MAIL AS WELL AS A REQUEST FOR THE DENTIST TO SEND THE DEVICE TO NSK AMERICA. NO FURTHER INFO IS AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFO IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS INITIAL MEDWATCH REPORT, A FOLLOW-UP MEDWATCH WIL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, NSK AMERICA CORPORATION RECEIVED A TELEPHONIC COMPLAINT FROM DR (B)(6) OF A NSK HANDPIECE ALLEGEDLY CAUSING A BURN TO THE PT ON (B)(6) 2013. THE NSK AMERICA EMPLOYEE CONTACTED BY THE DENTIST COLLECTED THE FOLLOWING INFO: HANDPIECE HEATED UP AND CAUSED A 2ND DEGREE BURN ABOUT 1 CM AREA AND SUBSEQUENT HEALING OF THE WOUND LEFT A SLIGHT SCAR. NSK AMERICA HAS REQUESTED ADDITIONAL INFO ON LOCATION OF BURN FROM THE DENTIST. PROCEDURE BEING PERFORMED WAS A WISDOM TOOTH EXTRACTION. PATIENT WAS AWAKE UNDER LOCAL ANESTHESIA. HANDPIECE WAS SENT FOR SERVICE TO A THIRD PARTY SERVICER, BUT NOT TO NSK AMERICA. DENTIST SENT THE HANDPIECE TO THE THIRD PARTY SERVICER, AFTER THE INCIDENT. DENTIST STATED REASON FOR DELAY IN REPORTING WAS THAT SHE (DENTIST) WAS UNABLE TO FIND CONTACT INFO FOR NSK AMERICA. DENTIST IS NOT CONCERNED THAT THE PT MAY SEEK ADDITIONAL DAMAGES FROM THE DENTIST FOR COSMETIC PROCEDURES AS A RESULT OF THE BURN. THEREFORE THE DENTIST WANTED TO LODGE A FORMAL COMPLAINT NOW WITH NSK AMERICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441542 NSK HANDPIECE, ROTARY BONE CUTTING KMW NAKANISHI INC SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention