BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER HYDROPHILIC COATED

    MDR report key: 7143552 · Received December 22, 2017

    Report

    Report Number
    3005471919-2017-00010
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 24, 2017
    Report Date
    December 22, 2017
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    PMA / PMN Number
    K132500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PATIENT (USER) REPORTED A URINARY TRACT INFECTION (UTI) COINCIDING WITH HIS ROUTINE URINARY CATHETERIZATION REGIMEN. PATIENT STATED HE IS NOT SURE IF UTI WAS DUE TO CATHETER OR DUE TO HYGIENE PRACTICES BEFORE OR DURING CATHETERIZATION. PATIENT PRESCRIBED ANTIBIOTIC AND HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921429 CURE CATHETER HYDROPHILIC COATED URINARY CATHETER EZD CURE MEDICAL LLC HM16 170517-1

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other