BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX SELF-ADHERING MALE EXTERNAL CATHETER

    MDR report key: 11700407 · Received April 21, 2021

    Report

    Report Number
    1018233-2021-02232
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 30, 2021
    Manufacturer
    COLOPLAST HUNGARY
    Product Code
    NNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADHESIVE OF MALE EXTERNAL CATHETER WAS TOO STRONG. ALSO MALE EXTERNAL CATHETERS WERE DIFFICULT TO UNROLL AND DIFFICULT TO REMOVE. END USER HAD TO USE SCISSORS TO REMOVE THE MALE EXTERNAL CATHETER AND NOT USING ANY WATER OR ADHESIVE REMOVER WHEN ATTEMPTING TO REMOVE THE PRODUCT. STATED THAT THE SKIN WAS TENDER WHERE THE PRODUCT ADHERES AND THE USER HAD SPOKE WITH PHARMACIST AND DOCTOR ABOUT THE ISSUE. ALSO CONFIRMED THAT THE END USER STORED THE PRODUCTS IN A COOL DRY AREA. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600834 ULTRAFLEX SELF-ADHERING MALE EXTERNAL CATHETER MALE EXTERNAL CATHETER NNX COLOPLAST HUNGARY 7664727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other