BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA CATHETER

    MDR report key: 12708319 · Received October 27, 2021

    Report

    Report Number
    3005471919-2021-00067
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    May 1, 2021
    Report Date
    October 27, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    KOD
    PMA / PMN Number
    K080881
    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 SHE NOTICED NO DEFECTS OR MALFUNCTION WITH THE ULTRA 14 CATHETER. THE PATIENT SAID SHE WAS CHANGING BACK TO THE TWIST CATHETER, T14, SHE USED IN THE PAST AND PROVIDED THE LOT NUMBER 210111-1 FOR THE T14 CATHETER.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID THESE CATHETERS WERE CAUSING URINARY TRACT INFECTIONS (UTI'S). DURING FOLLOW-UP, THE PATIENT CONFIRMED SHE ACQUIRED A UTI IN MAY, WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE, BUT THE INFECTION RETURNED A WEEK LATER. THIS WAS REPEATED FOR FIVE TREATMENTS, AND SHE FINISHED ANOTHER DOSE OF ANTIBIOTIC IN SEPTEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604756 ULTRA CATHETER URINARY CATHETER KOD CURE MEDICAL LLC ULTRA14

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other