BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICOLET

    MDR report key: 233532 · Received July 26, 1999

    Report

    Report Number
    MW1016817
    Event Type
    Malfunction
    Date Received
    July 26, 1999
    Date of Event
    June 21, 1999
    Report Date
    July 19, 1999
    Manufacturer
    NICOLET BIOMEDICAL, INC.
    Product Code
    IKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN "ELECTRICAL" SMELL WAS NOTED AND FOUND TO ORIGINATE FROM THE STIMULATOR THAT WAS ATTACHED TO THE PT'S ANKLES. IT WAS TURNED ON BUT THE PT WAS NOT BEING STIMULATED AT THE TIME OF THE INCIDENT. THE STIMULATOR WAS DISCONNECTED AND UNPLUGGED WITH NO APPARENT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLET ELECTRICAL STIMULATOR IKN NICOLET BIOMEDICAL, INC. VIKING IV *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR