BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED MEDICAL SUPPLIES MEDIUM VISCOSITY ULTRASOUND GEL

    MDR report key: 12301587 · Received August 9, 2021

    Report

    Report Number
    MW5103127
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    July 31, 2021
    Report Date
    August 6, 2021
    Manufacturer
    UNK
    Product Code
    ITX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FELT A BURNING SENSATION WHILE USING THE PRODUCT. ONLY USED PRODUCT TWICE BECAUSE OF THIS. THE FIRST TIME WAS MID (B)(6). THE MOST RECENT WAS USED ON THE EVENING OF SATURDAY, (B)(6) 2021. CLEANED SKIN AND TOOLS THAT HAD THIS PRODUCT ON THEM BOTH EACH TIME. SWITCHED TO AN OIL BASED PRODUCT ON WEDNESDAY (B)(6) 2021 EVERYTHING WAS FINE. NO SIDE EFFECT WITH THE OTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191400 RED MEDICAL SUPPLIES MEDIUM VISCOSITY ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX UNK B046

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other