BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIST THERAPY SYSTEM

    MDR report key: 917366 · Received September 21, 2007

    Report

    Report Number
    3004580659-2007-00003
    Event Type
    Other
    Date Received
    September 21, 2007
    Date of Event
    August 26, 2007
    Report Date
    September 20, 2007
    Manufacturer
    CELLERATION, INC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MIST THERAPY SYSTEM INVOLVED IN THE REPORTED EVENT IS MANUFACTURED IN 06/2006. THE FACILITY HAS TWO UNITS, AND IT WAS UNCLEAR AS TO WHICH WAS INVOLVED IN THE EVENT.

    Description of Event or Problem · 1

    THE TREATMENT NURSE WAS HAVING ISSUES WITH GETTING THE APPLICATOR TO WORK WHILE ADMINISTERING TREATMENT WITH THE MIST THERAPY SYSTEM. SHE DID NOT DEACTIVATE THE SYSTEM WHEN REMOVING THE APPLICATOR TIP. THE NURSE PULLED OFF THE APPLICATOR TO RE-SEAT IT ON THE TRANSDUCER. HER MIDDLE LEFT FINGER BRUSHED THE TRANSDUCER TIP AND SHE RECEIVED A SLIGHT FRICTION BURN. THE TREATMENT NURSE THEN PROCEEDED TO USE THE MIST THERAPY SYSTEM TO TREAT THE BURN. THE BURN DUD NOT PRODUCE A BLISTER ON THE FINGER, NOR WAS THERE ANY FURTHER INJURY TO THE FINGER. THE BURN HAS NOT PRESENTED ANY LONG-TERM PROBLEM FOR THE TREATMENT NURSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other