BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA CATHETER

    MDR report key: 11904089 · Received May 28, 2021

    Report

    Report Number
    3005471919-2021-00051
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 28, 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 WITH THE ULTRA14 CATHETERS AND PREFERS THE ULTRA TO OTHER PRE-LUBRICATED ONES. SHE DISCARDED THE UNITS SO DOES NOT KNOW THE LOT NUMBER OF THE ONES SHE USED.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID SHE HAD ANOTHER URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE AND SHE IS ON MEDICINE NOW TO CLEAR IT UP. DURING FOLLOW-UP, THE PATIENT SAID SHE WAS PRESCRIBED AN ANTIBIOTIC AND TOOK THE FULL COURSE. UNFORTUNATELY, HER SYMPTOMS HAVE RETURNED SO SHE WILL BE CALLING HER DOCTOR TO ASK FOR ANOTHER DOSE OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798022 ULTRA CATHETER URINARY CATHETER KOD CURE MEDICAL LLC ULTRA14

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other