BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEE/8-3 MHZ TRANSDUCER

    MDR report key: 2655799 · Received April 27, 2009

    Report

    Report Number
    3032367-2009-00002
    Event Type
    Other
    Date Received
    April 27, 2009
    Date of Event
    March 26, 2009
    Report Date
    April 24, 2009
    Manufacturer
    SONOSITE,INC.
    Product Code
    IYN
    PMA / PMN Number
    K053069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED A COPY OF THE CIDEX OPA MFR'S INSTRUCTIONS FOR REFERENCE AND ADVISED TO FOLLOW THESE INSTRUCTIONS SHOULD THEY CHOOSE TO CONTINUE TO USE CIDEX OPA. IN ADDITION, THEY WERE PROVIDED A COPY OF THE TEE CARE INSTRUCTIONS WHICH INCLUDES A LIST OF ALTERNATE CLEANING METHODS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SONOSITE TEE/8-3 MHZ TRANSESOPHAGEAL TRANSDUCER LEFT BLACK MARKS ON THE PT'S SKIN IN THE AREA WHERE THE TRANSDUCER SHAFT RESTED AGAINST THE PT'S CHEEK. NO PERMANENT DAMAGE OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEE/8-3 MHZ TRANSDUCER TRANSESOPHAGEAL ULTRASOUND TRANSDUCER IYN SONOSITE,INC. P05183

    Patients

    Seq Age Sex Outcome Treatment
    1