BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIST THERAPY SYSTEM 5.0

    MDR report key: 863141 · Received June 7, 2007

    Report

    Report Number
    3004580659-2007-00001
    Event Type
    Other
    Date Received
    June 7, 2007
    Date of Event
    May 10, 2007
    Report Date
    June 7, 2007
    Manufacturer
    CELLERATION, INC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED, FAILURE ANALYSIS WILL BE PERFORMED BY THE MFR AND A SUPPLEMENTAL REPORT FILED AT THAT TIME.

    Description of Event or Problem · 1

    PHYSICAL THERAPIST (PT) SAID SHE FELT A SENSATION IN HER ARM, LIKE A WAVE OR CURRENT, STARTING AROUND HER FOREARM AND UP TO HER SHOULDER. SHE SAID SHE DIDN'T CONNECT THE SENSATION WITH THE USE OF THE MIST SYSTEM UNTIL SHE STARTED A TREATMENT ON ANOTHER PT, AND THE SENSATION HAPPENED AGAIN WHEN SHE TURNED THE TRANSDUCER BUTTON POWER ON. SHE SAID SHE WAS HOLDING THE TRANSDUCER WITHOUT LEANING HER ARM ON ANYTHING, HORIZONTALLY, WITH HER ONE HAND FIRMLY AROUND THE CENTER OF THE TRANSDUCER, NOT TOUCHING EITHER THE TRANSDUCER CORD CONNECTION OR THE POWER BUTTON. WHEN SHE TURNED THE TRANSDUCER POWER BUTTON OFF, THE "CURRENT" STOPPED. SHE SAID SHE WAS WEARING NO JEWELRY ON THAT ARM, SAW NO ALARMS ON THE HE MIST SYSTEM, AND THAT THE UNIT APPEARED TO BE OPERATING NORMALLY. SHE HAD USED THAT UNIT MANY TIMES BEFORE, AS HAD OTHER PTS IN HER DEPT. NO ONE ELSE HAD EXPERIENCED THE SENSATION. THEY DISCONTINUED USE OF THIS SYSTEM ONCE SHE REPORTED THE PROBLEM TO HER SUPERVISOR IN THE DEPARTMENT. THEY DID NOT TRY TO RECREATE THE PROBLEM ON SITE. THEY HAVE ALL USED THE OTHER MIST THERAPY UNIT AT THEIR SITE SINCE, WITH NO RECURRENCE OF THIS SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIST THERAPY SYSTEM 5.0 UNK NRB CELLERATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other