BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA CATHETER

    MDR report key: 10081031 · Received May 21, 2020

    Report

    Report Number
    3005471919-2020-00035
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    April 15, 2020
    Report Date
    May 21, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTED A SECOND POTENTIAL LOT NUMBER, 190826-1, WHEN USING THE ULTRA M14 CATHETERS. DURING FOLLOW-UP, THE PATIENT REPORTED SOME UNITS WERE SLIPPERY, WHILE OTHERS WERE MORE STICKY, AND THOUGHT THE UTI'S MIGHT HAVE BEEN CAUSED BY EXPERIENCING MORE FRICTION OVER TIME WHEN CATHETERIZING.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID HE RECEIVED A URINARY TRACT INFECTION (UTI) FROM USING THE ULTRA M14 CATHETERS. DURING FOLLOW-UP, THE PATIENT REPORTED HE HAD MULTIPLE UTI'S (POSSIBLY 3) DUE TO MORE FRICTION THAN USUAL WHEN CATHETERIZING WHILE USING THE ULTRA M14, BUT CAN'T REMEMBER THE DATES OF THE EVENTS THAT OCCURRED BETWEEN DECEMBER 2018 AND MARCH 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542341 ULTRA CATHETER URINARY CATHETER KOD CURE MEDICAL LLC ULTRA M14 190922-1 00815947021069

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other