BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 24667836 · Received March 23, 2026

    Report

    Report Number
    MW5185627
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    October 19, 2025
    Report Date
    February 13, 2026
    Manufacturer
    UNKNOWN
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORT: (B)(4): LLT CODES: 10005116: BLEEDING GASTROINTESTINAL. NARRATIVE: PATIENT HISTORY OF URINARY RETENTION WITH FOLEY CATHETER PRESENT TO OUTSIDE EMERGENCY ROOM WITH HEMATURIA FOR 3 DAYS. CATHETER WAS REPLACED TWO DAYS PRIOR. PATIENT HAD WORSENING ANEMIA WITH HEMOGLOBIN 10.6 TO 9.2 IN 3 DAY SPAN. PATIENT SPENT ONE NIGHT IN HOSPITAL. NO INTERVENTION PER UROLOGY. H/H IMPROVED. ASPIRIN WAS RESTARTED AT DISCHARGE. RIVAROXABAN WAS HELD UNTIL UROLOGIC PROCEDURE TO CHANGE HIS CATHETER A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732625 FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization ASPIRIN 81MG.| RIVAROXABAN 20MG.