BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED MEDICAL SUPPLIES ECO-MED MEDIUM VISCOSITY ULTRASOUND GEL

    MDR report key: 12294402 · Received August 6, 2021

    Report

    Report Number
    MW5103097
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    July 15, 2021
    Report Date
    August 5, 2021
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECENTLY BOUGHT THE ECO MED BLUE GEL INLINE AT (B)(6) FOR MICRODERMABRASION FOR MY FACE. I NOTICED ABOUT TWO DAYS AFTERWARD THAT MY FACE WAS SWELLING AND STARTED TO BREAK OUT WITH LESIONS. IT HAS GOTTEN WORSE. I GOT THE NOTICE TODAY IN MY EMAIL ABOUT THIS GEL I ORDERED AND THE CONTAMINATION. I CAN BARELY TOUCH THE LESIONS AND THEY BLEED A LOT WHEN PRESSED. THEY HAVE SPREAD TO MY ARMS AND BACK OF LEGS AND BUTTOCKS, FRONT OF MY THIGH AND FACE. MY EYESIGHT HAS BEEN BLURRY LATELY AND I'VE HAD PINKEYE 3 TIMES SINCE USING IT. I HAVE NOT BEEN TO THE DOCTOR YET. I HAVE BEEN TRYING TO SELF TREAT AT HOME. CAN YOU RECOMMEND A DOCTOR OR GROUP TO GO TO?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188783 RED MEDICAL SUPPLIES ECO-MED MEDIUM VISCOSITY ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX B045

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| S