BEUDAMED
    FDA Adverse Event Summary report: N

    FORZA F5

    MDR report key: 4298123 · Received November 13, 2014

    Report

    Report Number
    9611253-2014-00028
    Date Received
    November 13, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 15, 2017
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE TRIED TO GET MORE INFORMATION FOR THIS EVENT. WE ASKED B-USA TO GET MORE DETAIL INFORMATION FROM PATIENT ON (B)(4) 2014 AND (B)(4) 2014 BY E-MAIL. BUT WE COULD NOT GET ANY ADDITIONAL INFORMATION UP TO NOW. AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (FORZA F5, SERIAL NO. (B)(4)). NAKANISHI INC. CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM BRASSELER USA (B-USA) TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK FOR B-USA. B-USA EVENT SUMMARY: PATIENT'S RIGHT BUCCAL MUCOSA WAS BURNED DURING PROCEDURE. NAKANISHI HAS REQUESTED ADDITIONAL INFORMATION FROM B-USA REGARDING THIS EVENT VIA WRITTEN LETTER SENT (B)(4) 2014. B-USA DID NOT RETURN HANDPIECE TO NSK FOR THE MANUFACTURER'S EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734550 FORZA F5 HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT, DENTAL, EGS NAKANISHI, INC. (NSK) FORZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other