BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONIC GENERIC ULTRASOUND TRANSMISSION GEL

    MDR report key: 2427803 · Received January 19, 2012

    Report

    Report Number
    2241583-2012-00001
    Event Type
    Other
    Date Received
    January 19, 2012
    Date of Event
    July 21, 2006
    Report Date
    July 21, 2006
    Manufacturer
    PHARMACEUTICAL INNOVATIONS, INC.
    Product Code
    GYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACEUTICAL INNOVATIONS RECEIVED A COMPLAINT ON (B)(4) 2006, FROM (B)(6) MEDICAL CENTER, (B)(4). ON (B)(4) 2006, AN MDR WAS RECEIVED AT PHARMACEUTICAL INNOVATIONS FROM THE FDA. PHARMACEUTICAL INNOVATIONS HEAD CHEMIST SPOKE WITH (B)(6) AT (B)(6) MEDICAL CENTER ON (B)(4) 2006, AND SHE CONFIRMED THE CONTAMINATION WAS NOT FROM PHARMACEUTICAL INNOVATION'S GEL. THE PART NUMBER AND LOT NUMBER REFERENCED ON THE MDR WAS NOT PHARMACEUTICAL INNOVATIONS, INC. NOMENCLATURE FOR PART NUMBER OR LOT NUMBER. THE PART NUMBER P11111-05 IS MANUFACTURED BY JOH ALI MEDICAL, INC. THIS MDR WAS NEVER COMPLETED AND SUBMITTED TO THE FDA. THE HEAD CHEMIST DID NOT SUBMIT THE NECESSARY DOCUMENTATION IN 2006. AS A RESULT OF A RECENT FDA INSPECTION THIS ISSUE WAS BROUGHT TO THE ATTENTION OF PHARMACEUTICAL INNOVATIONS, INC. MANAGEMENT AND IS NOW BEING ADDRESSED.

    Description of Event or Problem · 1

    EVENT DESC: 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 LITERS CONTAINERS WITH 8 OZ REFILLABLE BOTTLES. BOTTLES ARE TOP OFF AND NOT CAPPED. EIGHT OUNCES 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 AND REST OF THE HOSPITAL BUYS THE 8 OZ BOTTLES. 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 IS A COMMON ORGANISM. INVESTIGATION IS ONGOING. DEVICE USAGE PROBLEM: OTHER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R