BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK EX-5 STR

    MDR report key: 4586822 · Received March 3, 2015

    Report

    Report Number
    9611253-2015-00017
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Manufacturer
    NAKANISHI, INC. (NSK0
    Product Code
    EGS
    PMA / PMN Number
    K962540
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) (MFR) EXAMINED THE DHR FOR DEVICE (EX-5 STR, LOT NO. 1107). NAKANISHI INC. CONDUCTED THAT NO PROBLEMS HAD OCCURRED DURING MFG OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146285 NSK EX-5 STR HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK0

    Patients

    Seq Age Sex Outcome Treatment
    1