BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIST THERAPY SYSTEM

    MDR report key: 863140 · Received June 7, 2007

    Report

    Report Number
    3004580659-2007-00002
    Event Type
    Other
    Date Received
    June 7, 2007
    Date of Event
    May 14, 2007
    Report Date
    June 7, 2007
    Manufacturer
    CELLERATION, INC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED A RASH AROUND THE WOUND BEING TREATED BY MIST THERAPY. THE RASH WAS IN THE AREA WHERE THE SALINE WAS APPLIED BY THE MIST. THE FAMILY OF THE PT TOLD THE NURSING HOME THAT THE PT HAS HAD THE SAME REACTION TO SODIUM CHLORIDE BEFORE. IT WAS UNK TO CELLERATION WHETHER THIS ALLERGY WAS DOCUMENTED BY THE SITE AS A PRE-EXISTING CONDITION. THE PT'S RASH SUBSIDED AFTER DISCONTINUING USE OF THE SALINE MIST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other