BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

    MDR report key: 10770033 · Received November 2, 2020

    Report

    Report Number
    10770033
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 21, 2020
    Manufacturer
    PARKER LABORATORIES INC
    Product Code
    IYO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED FOR VASCULAR TESTING. ULTRASONIC GEL WAS APPLIED TO THE LEG AND THE GEL WAS TOO HOT CAUSING A BURN AND REDDENING OF THE SKIN IN THE RIGHT GROIN AND TO THE MEDIAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236192 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PARKER LABORATORIES INC

    Patients

    Seq Age Sex Outcome Treatment
    1