BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIST THERAPY SYSTEM

    MDR report key: 1278311 · Received December 30, 2008

    Report

    Report Number
    3004580659-2008-00005
    Event Type
    Other
    Date Received
    December 30, 2008
    Date of Event
    December 2, 2008
    Report Date
    December 30, 2008
    Manufacturer
    CELLERATION, INC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WOUND CARE NURSE STATED SHE HAD "BURNED HER HAND" ON THE TRANSDUCER WAND. SHE STATED THERE WAS NO BREAK IN THE SKIN, BUT THIS HAD HAPPENED BEFORE TO THE TECH AS WELL. THE NURSE REPORTED THE EVENT TO THE EMPLOYEE HEALTH NURSE AT THE FACILITY. THE NURSING STAFF USING THE DEVICE HAVE BEEN RETRAINED AND REMINDED THAT THE BURN IS A FRICTION BURN AND NOT HEAT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIST THERAPY SYSTEM NONE NRB CELLERATION, INC. CP-80004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other