BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIST THERAPY SYSTEM

    MDR report key: 1881701 · Received October 22, 2010

    Report

    Report Number
    3004580659-2010-00001
    Event Type
    Other
    Date Received
    October 22, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CELLERATION, INC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TREATMENT NURSE WAS TREATING A PT AND SAID SHE TOUCHED THE TIP OF THE TRANSDUCER WITH THE PALM OF HER GLOVED RIGHT HAND BECAUSE SHE DIDN'T THINK SHE WAS SEEING ENOUGH SALINE MIST COMING OFF OF THE TRANSDUCER. SHE RECEIVED AN ACOUSTIC BURN, AND IMMEDIATELY REMOVED HER HAND. NO DAMAGE TO HER GLOVE OR SKIN. SHE SAID SHE REALIZED RIGHT AWAY THAT SHE WASN'T SUPPOSED TO TOUCH IT WHILE IT WAS ON. BESIDES THE INITIAL SENSATION ON HER HAND, SHE DID NOT HAVE ANY LONG LASTING PAIN OR ANY DAMAGE AS A RESULT OF THE INCIDENT.

    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