BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED MEDICAL SUPPLIES: MEDIUM VISCOSITY ULTRASOUND GEL MULTI-PURPOSE BLUE COLOR

    MDR report key: 12301580 · Received August 9, 2021

    Report

    Report Number
    MW5103126
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    August 4, 2021
    Report Date
    August 6, 2021
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED AN EMAIL FROM (B)(6) STATING THERE WAS A RECALL DUE TO BACTERIA FOUND IN PRODUCT. RED MEDICAL SUPPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191399 RED MEDICAL SUPPLIES: MEDIUM VISCOSITY ULTRASOUND GEL MULTI-PURPOSE BLUE COLOR TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX B030

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR