BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE ULTRASOUND GEL

    MDR report key: 12342926 · Received August 18, 2021

    Report

    Report Number
    MW5103349
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    July 22, 2021
    Report Date
    August 17, 2021
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    MUI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVELOPED BACTEREMIA WITH BURKHOLDERIA - LIKELY EXPOSURE TO MEDICHOICE ULTRASOUND GEL - BEFORE RECALL NOTICE WAS ISSUED. ONE OF SEVEN PATIENTS AT OUR HOSPITAL WITH THIS INFECTION- WE HAD THE AFFECTED LOT NUMBERS OF MEDICHOICE ULTRASOUND GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232084 MEDICHOICE ULTRASOUND GEL MEDIA, COUPLING, ULTRASOUND MUI OWENS & MINOR DISTRIBUTION, INC. B030
    1232085 MEDICHOICE ULTRASOUND GEL MEDIA, COUPLING, ULTRASOUND MUI OWENS & MINOR DISTRIBUTION, INC. B041
    1232086 MEDICHOICE ULTRASOUND GEL MEDIA, COUPLING, ULTRASOUND MUI OWENS & MINOR DISTRIBUTION, INC. B048

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization