BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED MEDICAL SUPPLIES ULTRASOUND GEL

    MDR report key: 12474845 · Received September 14, 2021

    Report

    Report Number
    MW5103923
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    July 20, 2021
    Report Date
    September 11, 2021
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD FEVER FOR OVER TWO WEEKS AFTER I STARTED USING THIS GEL WITH AN ULTRASOUND MACHINE FOR A TUMMY TUCK I HAD RECENTLY. I GOT AN INFECTION IN MY BELLY BUTTON AND IT HAS NOT HEAL AND NEED TO GET A NEW SURGERY TO FIX; I WAS TOLD BY MY DOCTOR THAT WAS DAMAGED. RED MEDICAL SUPPLIES LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368941 RED MEDICAL SUPPLIES ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX B054

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR