BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED MEDICAL SUPPLIES, MEDIU VISCOSTY, ULTRASOUND GEL, BLUE COLOR

    MDR report key: 12318381 · Received August 12, 2021

    Report

    Report Number
    MW5103226
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    June 10, 2021
    Report Date
    August 11, 2021
    Manufacturer
    ECO-MED PHARMACEUTICALS, INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE TWO BOTTLES OF BLUE COLOR (ULTRASOUND GEL), I BECAME HOSPITALIZED WITH A BACTERIAL INFECTION THAT SPREAD TO MY BLOOD. I WAS ADMITTED FOR SEVERAL DAYS AND WAS DIAGNOSED WITH SEPSIS. I AM STILL UNDER THE CARE OF A PHYSICIAN. I AM STILL BEING TREATED AND MONITORED AS A RESULT OF USING THIS "PRODUCTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212276 RED MEDICAL SUPPLIES, MEDIU VISCOSTY, ULTRASOUND GEL, BLUE COLOR TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX ECO-MED PHARMACEUTICALS, INC. B030

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization