BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTILE SOAP TOWELETTE

    MDR report key: 13059340 · Received December 22, 2021

    Report

    Report Number
    13059340
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 10, 2021
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Product Code
    KOY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PACKAGING FOR PDI NAIL POLISH REMOVER PADS AND THE PDI CASTILE SOAP TOWELETTE ARE SIMILAR IN PACKING, SIZE, AND DESIGN. THERE IS A POTENTIAL FOR THE PRODUCTS TO BE SWITCHED WHEN USED ON OR BY A PATIENT. SUGGESTION MADE FOR THE MANUFACTURER TO EVALUATE DESIGN FOR OPPORTUNITIES. NURSE WAS GETTING A CLEAN CATCH URINE, AND PT WAS GIVEN NAIL POLISH REMOVER WIPES, (THE WIPES WERE ALONGSIDE THE URINE CUPS) INSTEAD OF THE SOAP CASTILE WIPES. MOM ASSISTED IN WIPING AND PT BEGAN TO CRY, STATING IT WAS "BURNING". WRITER NOTED THAT THE WRONG WIPES WERE OPENED. IMMEDIATELY USED WARM WATER WIPES TO REMOVE THE NAIL POLISH REMOVER. PT FELT RELIEF IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964857 CASTILE SOAP TOWELETTE PROFESSIONAL USE SKIN CLEANSER TOWELETTE KOY PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown