BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER FEMALE

    MDR report key: 11720833 · Received April 23, 2021

    Report

    Report Number
    3005471919-2021-00041
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    January 15, 2021
    Report Date
    April 23, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    UDI-DI
    008159947020048
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP, THE PATIENT SAID THE CATHETERS WORK FINE AND PROBLEM WASN'T DUE TO SENSITIVITY TO THE LUBRICANT OF THE K1 CATHETER INSERTION KIT OR DUE TO ANY DEFECT OR MALFUNCTION. SHE SAID THAT HER PROBLEM WAS THE SIZE OF THE CATHETER WAS TOO BIG SO SHE IS CHANGING TO A SMALLER FRENCH SIZE.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID THE CATHETERS ARE CAUSING HER IRRITATION AND URINARY TRACT INFECTIONS (UTI'S). DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE, BUT THE INFECTION RETURNED. SHE HAD TO BE PRESCRIBED ANOTHER ANTIBIOTIC FOR A TOTAL OF THREE TIMES, BUT THE INFECTION SEEMED TO RETURN AGAIN. THE PATIENT WILL SEE HER DOCTOR TO CONFIRM IF THE INFECTION RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615968 CURE CATHETER FEMALE URINARY CATHETER EZD CURE MEDICAL LLC F14 201009-2 008159947020048

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other