BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUASONIC 100

    MDR report key: 12369921 · Received August 26, 2021

    Report

    Report Number
    12369921
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 16, 2021
    Report Date
    August 17, 2021
    Manufacturer
    PARKER LABORATORIES INC
    Product Code
    MUI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AQUASONIC 100 ULTRASOUND TRANSMISSION GEL - ACCORDING TO THE JOINT COMMISSION "SINCE THERE IS NO EFFECTIVE WAY TO DETERMINE WHETHER AN OPENED BOTTLE OF GEL HAS BEEN CONTAMINATED, GENERAL GUIDELINES ARE THAT THE GEL SHOULD BE MARKED TO EXPIRE 28 DAYS AFTER OPENING. USING A WARMER FOR THE GEL DOES NOT IMPACT THE EXPIRATION TIME." OUR REQUEST IS FOR THE MANUFACTURER TO HAVE AN AREA ON THE GEL BOTTLE /CONTAINER WHERE THE USER CAN RECORD THE EXPIRATION DATE. THIS WOULD IMPROVE PATIENT SAFETY AND ASSIST WITH COMPLIANCE OF RECORDING EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266330 AQUASONIC 100 MEDIA,COUPLING,ULTRASOUND MUI PARKER LABORATORIES INC ULTRASOUND TRANSMISSION GEL

    Patients

    Seq Age Sex Outcome Treatment
    1