BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER

    MDR report key: 11325285 · Received February 12, 2021

    Report

    Report Number
    3005471919-2021-00023
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 2, 2021
    Report Date
    February 12, 2021
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    PMA / PMN Number
    K072539
    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 NOTICED NO DEFECTS OR MALFUNCTION WITH THE M14 CATHETERS OR K1 INSERTION KITS. THE M14 CATHETER IS MOST RELEVANT TO THE DEVICE PROBLEM.

    Description of Event or Problem · 1

    INTERMITTENT CATHETER PATIENT (USER) SAID HE WAS RECENTLY TREATED FOR A URINARY TRACT INFECTION (UTI) CONCURRENT WITH CURE MEDICAL BRAND M14 CATHETER AND K1 INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD, LUBRICATING JELLY) USE. DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED AN ANTIBIOTIC, TOOK THE FULL COURSE, AND RECOVERED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217606 CURE CATHETER URINARY CATHETER EZD CURE MEDICAL LLC M14

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other