BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIST THERAPY SYSTEM

    MDR report key: 1079502 · Received July 17, 2008

    Report

    Report Number
    3004580659-2008-00003
    Event Type
    Other
    Date Received
    July 17, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CELLERATION, INC.
    Product Code
    NRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TREATMENT NURSE STATED THAT THE FRICTION BURN TO HIS FINGER OCCURRED WHEN HE WAS ATTEMPTING TO DEAL WITH THE TRANSDUCER BUTTON ON THE MIST THERAPY SYSTEM. THE BUTTON WAS NOT FUNCTIONING PROPERLY AND REQUIRED REPEATED "PRESSES" TO KEEP THE ULTRASOUND GOING TO COMPLETE THE PATIENT'S TREATMENT. THE NURSE STATED HE WAS NOT PAYING CLOSE ATTENTION TO WHERE HIS FREE HAND WAS, HE TOUCHED THE TIP OF THE TRANSDUCER AND RECEIVED THE FRICTION BURN. CELLERATION CUSTOMER SERVICE REVIEWED INSTRUCTIONS FOR USE WITH THE NURSE, AND HE WAS UNAWARE THAT THE TRANSDUCER WAS NOT TO BE TOUCHED WHILE ON. PROPER PROCEDURE WAS REVIEWED WITH THE NURSE, AND SALES REP WILL BE FOLLOWING UP WITH ANY ADDITIONAL TRAINING THAT MAY BE REQUIRED.

    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 UNK Other