BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER FEMALE

    MDR report key: 11762816 · Received May 3, 2021

    Report

    Report Number
    3005471919-2021-00044
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 3, 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 THERE WERE NO DEFECTS OR MALFUNCTION WITH THE F14 UNITS. SHE THINKS IT IS DIFFICULT FOR HER TO MAINTAIN STERILITY WHEN CATHETERIZING. THE PATIENT ALSO REPORTED REUSE OF THE CATHETER THAT MAY HAVE CONTRIBUTED TO HER GETTING AN INFECTION.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID SHE CURRENTLY HAS A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE AND IS USING MORE CATHETERS THAN USUAL. DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC AND IS STILL TAKING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659972 CURE CATHETER FEMALE URINARY CATHETER EZD CURE MEDICAL LLC F14 180820-1 008159947020048

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other