BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER HYDROPHILIC COATED

    MDR report key: 11679495 · Received April 16, 2021

    Report

    Report Number
    3005471919-2021-00039
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    September 20, 2020
    Report Date
    April 16, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    PMA / PMN Number
    K132500
    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 HE HAS NOT NOTICED ANY DEFECT OR MALFUNCTION WITH THE HM16 UNITS.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID HE GOT A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE. DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE BUT THE INFECTION KEEPS RETURNING OVER AND OVER AGAIN. HE HAS BEEN PLACED ON AN ANTIBIOTIC WHICH HE TAKES TWICE A WEEK, AND THE INFECTION STILL HAS NOT BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575008 CURE CATHETER HYDROPHILIC COATED URINARY CATHETER EZD CURE MEDICAL LLC HM16

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other