BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUJA FEMALE CATHETER

    MDR report key: 22039190 · Received May 16, 2025

    Report

    Report Number
    MW5170515
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 12, 2025
    Manufacturer
    COLOPLAST HUNGARY KFT
    Product Code
    EZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I EXPERIENCED A SIGNIFICANT ALLERGIC-TYPE REACTION AFTER USING THE COLOPLAST LUJA FEMALE CATHETER, WHICH I BELIEVE WAS CAUSED BY THE LUBRICANT OR SURFACE COATING. SYMPTOMS INCLUDED INTENSE ITCHING, REDNESS, AND INFLAMMATION IN THE PERINEAL AND ANAL REGION, WHICH PROGRESSIVELY WORSENED WITH CONTINUED USE. THE REACTION BEGAN TO RESOLVE WITHIN 36 HOURS OF DISCONTINUING USE AND FULLY SUBSIDED AFTER 4 DAYS. I HAVE SINCE RESUMED USING THE SPEEDICATH PLUS FEMALE CATHETER, WHICH I HAD USED PREVIOUSLY WITHOUT ISSUE, AND HAVE EXPERIENCED NO ADVERSE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166683 LUJA FEMALE CATHETER CATHETER, STRAIGHT EZD COLOPLAST HUNGARY KFT 20054 10168184

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Disability| O CBD CORTICOBASAL DEGENERATION.| CHROMOLYN SODIUM.| CYTOMEL.| FAMOTIDINE.| HYDROXIZINE PERISTEEN ANAL IRRIGATION.| MAGNESIUM.| MELATONIN.| RESMED AIRCURVE 11.| SYNTHROID.| VITAMIN B (COMPLEX).| VITAMIN D.| WOMEN'S MULTI.| ZYRTEC.