BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SOUND GEL

    MDR report key: 101206 · Received June 27, 1997

    Report

    Report Number
    MW1011589
    Event Type
    Malfunction
    Date Received
    June 27, 1997
    Date of Event
    June 11, 1997
    Report Date
    June 27, 1997
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    THE TECHNOLOGIST WENT TO PERFORM A PROCEDURE AND PUT GEL ON PT'S BREAST AND PT BROKE OUT IN HIVES ALL OVER HER BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA SOUND GEL ULTRA SOUND GEL IYO PARKER LABORATORIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other