BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DANTEC

    MDR report key: 5497817 · Received March 14, 2016

    Report

    Report Number
    3004827015-2016-00003
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    February 18, 2016
    Report Date
    March 14, 2016
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    GXZ
    PMA / PMN Number
    K932059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED SEPARATION OF SCALP NEEDLE (PN 9013R0313) WHILE IN USE, LEAVING THE NEEDLE CANNULA STILL INSERTED IN THE PATIENT'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155673 DANTEC DISPOSABLE SCALP NEEDLE ELECTRODE GXZ ALPINE BIOMED APS 9013R0313 60552

    Patients

    Seq Age Sex Outcome Treatment
    1