BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MALE ULTRA

    MDR report key: 11866472 · Received May 21, 2021

    Report

    Report Number
    3005471919-2021-00048
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    February 28, 2021
    Report Date
    May 21, 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 HE SUFFERED NO TRAUMA, CUT, OR BLEEDING, AND NEVER NOTICED ANY DEFECTS OR MALFUNCTION WITH THE ULTRAM14 PRODUCT. HE DISCARDED THE ULTRAM14 UNITS. HIS DOCTOR ADVISED HIM TO CHANGE TO ANOTHER CATHETER BRAND WITH AN ANTIBIOTIC COATING TO HELP PREVENT UTI'S.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID HE HAS BEEN EXPERIENCING CHRONIC URINARY TRACT INFECTIONS (UTI'S) CONCURRENT WITH CATHETER USE AND IS FOLLOWING UP WITH A PHYSICIAN. DURING FOLLOW-UP, THE PATIENT SAID HE WAS HOSPITALIZED, GIVEN ANTIBIOTICS AND RELEASED, BUT THE INFECTION RECURRED. AFTER A SECOND DOSE OF ANTIBIOTICS, THE INFECTION RETURNED AGAIN. AFTER FINISHING THE THIRD DOSE OF ANTIBIOTICS, THE PATIENT HOPES THE INFECTION HAS BEEN RESOLVED, BUT WAS NOT CERTAIN IT WAS RESOLVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763162 CURE MALE ULTRA URINARY CATHETER KOD CURE MEDICAL LLC ULTRAM14

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O