BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK TI-MAX Z95L

    MDR report key: 3901588 · Received June 19, 2014

    Report

    Report Number
    1422375-2014-00004
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 29, 2014
    Report Date
    June 13, 2014
    Manufacturer
    NAKANISHI INC
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    INITIAL REVIEW OF RETURNED PACKAGE ON (B)(6) 2014 REVEALED AN ENCLOSED NOTE THAT STATED, "DR STATES IT BURNT PT." CONTACTED DISTRIBUTOR BY EMAIL REQUESTING ADDITIONAL INFO AND RECEIVED THE FOLLOWING RESPONSE ON (B)(6) 2014: "DEGREE OF BURN WAS 1ST AND 2ND DEGREE. THERE WAS SLOUGHING OF ISSUE. PROCEDURE BEING PERFORMED WAS A FILLING ON #14 O. NO NOVACAIN WAS NEEDED. THERE WERE NO ADDITIONS OF MALFUNCTION PRIOR TO THE EVENT. FIRST INDICATION THAT AN INJURY HAD OCCURRED WAS THE PT FLINCHED AND STATED THAT THE HANDPIECE WAS VERY HOT. TREATED WITH TOPICAL ANESTHETIC AND RECOMMENDED WARM SALT WATER RINSES AT HOME. THERE WAS NO FOLLOW UP WITH THE PT." INVESTIGATION BY (B)(4) SHOWS THAT HANDPIECE WAS RECEIVED FROM MANUFACTURER ON (B)(4) 2013 AND SOLD TO DISTRIBUTOR HENRY SCHEIN ON (B)(4) 2013. DEVICE AND ADDITIONAL INFO FORWARDED TO THE ORIGINAL MANUFACTURER ON (B)(6) 2014 FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360867 NSK TI-MAX Z95L ELECTRIC ATTACHMENT HANDPIECE, PRODUCT CODE: EGS EGS NAKANISHI INC Z95L

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention