BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFL38 13-6 (MHZ) TRANSDUCER

    MDR report key: 776512 · Received October 31, 2006

    Report

    Report Number
    3032367-2006-00002
    Event Type
    Injury
    Date Received
    October 31, 2006
    Date of Event
    October 22, 2006
    Report Date
    October 27, 2006
    Manufacturer
    SONOSITE,INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED THE SYSTEM AND TRANSDUCER INVOLVED THE INCIDENT TO BE RETURNED TO SONOSITE, INC. FOR EVALUATION, HOWEVER, THE EQUIPMENT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE REPORT WAS RECEIVED FROM A VETERINARY HOSPITAL. THE CUSTOMER STATED THAT HE WAS USING THE MICROMAXX ULTRASOUND SYSTEM AND HFL38 13-6 (MHZ) TRANSDUCER TO PERFORM A SCAN OF HIS OWN ELBOW. DURING THE EXAMINATION, THE DOCTOR ALLEGES THAT THE TRANSDUCER BECAME WARM CAUSING A REDDENTING OF THE AREA AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HFL38 13-6 (MHZ) TRANSDUCER ULTRASOUND TRANSDUCER ITX SONOSITE,INC. P05697-10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other