BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRASOUND IMAGING SYSTEM

    MDR report key: 20019 · Received February 28, 1995

    Report

    Report Number
    MW1005258
    Date Received
    February 28, 1995
    Date of Event
    January 22, 1995
    Report Date
    February 22, 1995
    Manufacturer
    DIASONICS, INC.
    Product Code
    IYO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DILATATION AND EVACUATION PROCEDURE WITH ULTRASOUND GUIDANCE, A REDDENED AREA WAS NOTED ON THE PT'S PELVIC AREA WHERE THE ULTRASOUND TRANSDUCER HAD BEEN PLACED. THE AREA MEASURED APPROX THREE INCHES IN DIAMETER. SILVADENE CREAM WAS APPLIED TO THE REDDENED AREA. MFR'S FIELD SERVICE REP WAS NOTIFIED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOUND IMAGING SYSTEM ULTRASOUND IMAGING SYSTEM IYO DIASONICS, INC. DRF-400

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR