BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED MEDICAL ULTRASOUND GEL BLUE

    MDR report key: 12307399 · Received August 10, 2021

    Report

    Report Number
    MW5103148
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    May 1, 2021
    Report Date
    August 7, 2021
    Manufacturer
    RED MEDICAL SUPPLIES, LTD / ECO-MED PHARMACEUTICALS, INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECALLED RED MEDICAL ULTRASOUND GEL BLUE, BY RED MEDICAL SUPPLIES LTD CAUSED INFECTED SEROMA REQUIRING ANTIBIOTICS FOR OVER 24 DAYS PLUS THREE ASPIRATIONS AND NOW PLASTIC SURGEON CONSULT FOR SCARRING, LONG TERM CORTISONE THERAPY AND SURGICAL INTERVENTION. THE COMPANY WILL NOT ALLOW REFUND OF RECALLED INFECTED PRODUCT THAT CAUSED THE INFECTION. COMPANY WEBSITE IS DIFFICULT FOR NURSES AND PATIENT TO NAVIGATE AND HOURS AWAITING ON THE PHONE. EMAILS TO RESOURCE ON RECALL WEBSITE ARE NOT BEING RETURNED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197493 RED MEDICAL ULTRASOUND GEL BLUE TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX RED MEDICAL SUPPLIES, LTD / ECO-MED PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention