BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORZA F5

    MDR report key: 4909842 · Received July 10, 2015

    Report

    Report Number
    9611253-2015-00098
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 8, 2015
    Report Date
    March 3, 2018
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DID NOT RETURN THE UNIT TO NAKANISHI (MANUFACTURER) FOR EVALUATION. AS OF THIS REPORT, NAKANISHI HAS NOT OBTAINED ANY ADDITIONAL INFORMATION. AS AN INVESTIGATIONAL APPROACH, NAKANISHI INC., JAPAN (MANUFACTURER) EXAMINED THE DHR FOR THE DEVICE (FORZA F5, (B)(4)). NAKANISHI CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016, (B)(4) HEARD FROM THE DISTRIBUTOR THAT NO ADDITIONAL INFORMATION REGARDING THE PATIENT WAS AVAILABLE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM (B)(4) TO NAKANISHI REGARDING A DEVICE MANUFACTURED BY NAKANISHI FOR (B)(4). EVENT SUMMARY BY (B)(4): CUSTOMER INDICATED THAT THE DOCTOR WAS DOING A RESIN, AND AS SOON AS THE DOCTOR STARTED THE PROCESS, THE HEAD CAP OF THE HANDPIECE OVERHEATED, SEARED THOUGH THE RUBBER DAM, AND BURNED THE PATIENT'S LIP. THE DOCTOR WAS ABLE TO USE ANOTHER HANDPIECE TO FINISH THE PROCEDURE. THE DOCTOR DETERMINED THAT NO MEDICAL INTERVENTION WAS REQUIRED BECAUSE ANY PERMANENT SCARRING WAS EXPECTED. THE DOCTOR ADVISED THE PATIENT TO KEEP APPLYING (B)(6) ON BURN UNTIL IT HEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448358 FORZA F5 HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. FORZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other