BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED MEDICAL SUPPLIES, MEDIUM VELOCITY ULTRASOUND GEL MULTI PURPOSE,

    MDR report key: 12481457 · Received September 15, 2021

    Report

    Report Number
    MW5104007
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    July 3, 2021
    Report Date
    September 14, 2021
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING ECO MED, RED GEL, I HAVE HAD A SORE ON THE SIDE OF FACE AND A SORE ON MY NECK, BREATHING ISSUES; INSIDE MY NOSE, IS A SORE AND AN EXCRUCIATING, RASH ON MY BUTTOCKS AND GENITALIA. I WAS TALKING WITH MY HUSBAND, TRYING TO ELIMINATE, ALL POSSIBILITIES, NOTHING. UNTIL, I SAW THE RECALL LETTER, FROM (B)(6) AND THINK, THIS IS WHAT HAS CAUSED THIS FOR MONTHS. THE NECK AND HEAD FIRST, THE SLIGHT BREATHING ISSUE, AND THEN, CURRENTLY, THE LARGE GENITAL RASH WITCH I FOUND A SORE ON THE INSIDE OF MY THIGH. I'VE NEVER HAD THIS ISSUE BEFOREHAND. THE CLINICS AND HOSPITALS, ARE BACKED UP HERE DUE TO 2, MAJOR HURRICANES AND COVID WHICH, I WON'T HAVE A DR, APPT, UNTIL (B)(6). ABOUT, THESE PROBLEMS, I'M CONCERNED, BECAUSE IT HAS SPREAD OR IS SPREADING. I HAVE USED THIS PRODUCT, AS DIRECTED. I REMOVE WITH TISSUES, AND USE ONLY EXTERNALLY. HOWEVER, I TAKE BATHS, NOT SHOWERS. I BELIEVE, THE RESIDUE OF THE GEL CONTAMINATED THE WARM WATER AND HENCE, THE PAINFUL, RASH ON MY BODY. THAT IS MY THOUGHTS, ON HOW IT MAY SPREAD. (B)(6), 2 MAJOR HURRICANES, JUST HIT AND COVID, HAS MADE IT NEARLY, IMPOSSIBLE TO GET A DR. VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375564 RED MEDICAL SUPPLIES, MEDIUM VELOCITY ULTRASOUND GEL MULTI PURPOSE, TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| S