BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER HYDROPHILIC COATED

    MDR report key: 11803577 · Received May 10, 2021

    Report

    Report Number
    3005471919-2021-00046
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    January 15, 2021
    Report Date
    May 10, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    UDI-DI
    00815947020045
    PMA / PMN Number
    K132500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP, THE PATIENT SAID HE HAS BEEN EXPERIENCING IRRITATION FROM CATHETERIZATION AND BLEEDING FOLLOWING CATHETERIZATION, AND TRIED ADDING LUBRICATING GEL TO THE HM14C TO EASE INSERTION BUT STILL EXPERIENCED THE SAME SYMPTOMS. HE WAS PLACED ON A FOLEY CATHETER TO GIVE HIS URETHRA A REST FROM THE BLEEDING INCIDENTS. HIS DOCTOR ADVISED PERHAPS THE CATHETER WAS TOO STIFF FOR HIS NEEDS, AND HE IS GOING TO TRY SAMPLES OF A SOFTER CATHETER. HE THOUGHT HE FELT ROUGH EDGES ON A FEW UNITS BUT DISCARDED THEM.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) REPORTED DISCOMFORT AND INFECTIONS CONCURRENT WITH CATHETER USE AND FEELS LIKE THERE IS AN EDGE ON THE CATHETER. DURING FOLLOW-UP, THE PATIENT CONFIRMED HE HAD SYMPTOMS OF A URINARY TRACT INFECTION (UTI) AND WAS PRESCRIBED AN ANTIBIOTIC WHICH HE IS STILL TAKING AND WAS PLACED ON A FOLEY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697592 CURE CATHETER HYDROPHILIC COATED URINARY CATHETER EZD CURE MEDICAL LLC HM14C 200601-1 00815947020045

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other