BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIST THERAPY SYSTEM

    MDR report key: 726835 · Received June 16, 2006

    Report

    Report Number
    3004580659-2006-00002
    Event Type
    Other
    Date Received
    June 16, 2006
    Date of Event
    April 24, 2006
    Report Date
    June 12, 2006
    Manufacturer
    CELLERATION, INC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DELAY IN FILING THIS REPORT DUE TO IT BEING THE FIRST FILED BY THE MANUFACTURER IN DEVICE HISTORY.

    Description of Event or Problem · 1

    EMPLOYEE AT HOSPITAL HAD EXPERIENCED AN INCIDENT WHER HER FINGERTIP TOUCHED THE TIP OF THE TRANSDUCER. THE INCIDENT WAS REPORTED DURING A SITE VISIT ON 4/24/2006 TO OUR SALES REPRESENTATIVE. THE EMPLOYEE WAS TRYING TO ADJUST THE APPLICATOR WHILE THE SYSTEM WAS TURNED ON, WHICH IS CONTRARY TO THE INSTRUCTIONS FOR USE. THE EMPLOYEE EXPERIENCED A BURN ON THEIR FINGER THAT WAS NO LONGER VISIBLE AT THE TIME OF THE REPORT. EMPLOYEE ACKNOWLEDGED THAT SHE SHOULD HAVE PAUSED THE SYSTEM PRIOR TO TRYING TO RE-SEAT THE APPLICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIST THERAPY SYSTEM * NRB CELLERATION, INC. CP-80004 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other