BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MALE ULTRA

    MDR report key: 9639904 · Received January 28, 2020

    Report

    Report Number
    3005471919-2020-00002
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    November 11, 2019
    Report Date
    January 27, 2020
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    KOD
    UDI-DI
    00815947021069
    PMA / PMN Number
    K080881
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT (USER) STATED THE PRE-LUBRICATED CATHETERS ARE TOO DRY AND HE HAS A HARD TIME INSERTING. HE CONTRACTED A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CATHETER USE BUT WAS UNCERTAIN IF THE CATHETERS CONTRIBUTED TO THE UTI HE ACQUIRED. HE TOOK ANTIBIOTICS AND REPORTED HIS UTI SYMPTOMS WERE GONE. PATIENT HAS CHANGED CATHETER BRANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99035 CURE MALE ULTRA URINARY CATHETER KOD CURE MEDICAL LLC ULTRA M14 190715-2 00815947021069

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other