BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK SGS-E2S

    MDR report key: 4778556 · Received May 14, 2015

    Report

    Report Number
    9611253-2015-00080
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    March 5, 2015
    Report Date
    August 2, 2019
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    KMW
    PMA / PMN Number
    K171155
    Removal / Correction Number
    9611253-060818-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, NSK AMERICA CORPORATION WAS MADE AWARE THAT A PT MAY HAVE BEEN BURNED BY A NSK HANDPIECE. TWO HANDPIECES WERE SENT TO NSK AMERICA BY DENTIST. THE DENTIST WAS NOT SURE WHICH HANDPIECE WAS USED. THE PIECE (SGS-E2S) SERIAL NUMBER (B)(4) AND SERIAL NUMBER (B)(4) WERE RECEIVED BY NSK AMERICA ON (B)(6) 2015. THE DENTIST STATED TO NSK AMERICA THAT THE BURN WAS A 2ND DEGREE BURN ON THE LEFT COMMISSURE OF THE LOWER LIP DURING EXTRACTION OF WISDOM TEETH. PT HAD NO PERMANENT DAMAGE AND WAS TREATED WITH ANTIBACTERIAL OINTMENT. THE INJURY WAS REPORTED TO BE HEALING NORMALLY. THIS REPORT IS FOR SERIAL NUMBER (B)(4) AND NSK AMERICA CORPORATION REPORTED FOR SERIAL NUMBER (B)(4) UNDER THE REPORT #1422375-2015-00007 (MFR REPORT # 9611253-2015-00081). NAKANISHI HAS STARTED THE EVAL PROCESS OF THE RETURNED PRODUCTS. NAKANISHI WILL SUBMIT ADD'L INFO INCLUDING RESULTS OBTAINED THROUGH THE INVESTIGATION AS A F/U REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315076 NSK SGS-E2S HANDPIECE ROTARY BONE CUTTING KMW NAKANISHI, INC. (NSK) SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other