BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONIC GENERIC ULTRASOUND TRANSMISSION GEL

    MDR report key: 740449 · Received July 21, 2006

    Report

    Report Number
    740449
    Event Type
    Injury
    Date Received
    July 21, 2006
    Date of Event
    July 21, 2006
    Report Date
    July 21, 2006
    Manufacturer
    PHARMACEUTICAL INNOVATIONS, INC
    Product Code
    MUI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFECTION CONTROL NOTED THAT NICU BABIES WITH POSITIVE CULTURES FOR PSEUDOMONAS HAD ALL GONE FOR ECHOCARDIOGRAMS. INVESTIGATION LEAD TO CULTURING THE GEL. ULTRASOUND GEL COMES IN 5 LITER CONTAINERS WITH 8 OZ REFILLABLE BOTTLES. BOTTLES ARE TOPPED OFF AND NOT CAPPED. 8 OZ BOTTLES AND 5 LITER BOTTLES TESTED POSITIVE FOR THE PSEUDOMONAS ORGANISM. A NEW UNOPENED CONTAINER WAS SENT OUT FOR CULTURE - RESULTS ARE PENDING. FOUR AREAS OF THE HOSPITAL USE THE REFILLABLE BOTTLES, THE REST OF THE HOSPITAL BUYS THE 8 OZ BOTTLE. INFECTION CONTROL DISCOURAGES TOPPING OFF ANY FLUIDS. IT IS NOT KNOWN FOR SURE IF THE ULTRASOUND GEL WAS THE SOURCE OF THE NICU BABIES' INFECTIONS AS IT IS A COMMON ORGANISM. INVESTIGATION AND TESTING IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONIC GENERIC ULTRASOUND TRANSMISSION GEL GEL, ULTRASOUND MUI PHARMACEUTICAL INNOVATIONS, INC UNK 122163
    2 SONIC GENERIC ULTRASOUND TRANSMISSION GEL GEL, ULTRASOUND MUI PHARMACEUTICAL INNOVATIONS, INC. UNK 122105

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O| R