BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER

    MDR report key: 7143549 · Received December 22, 2017

    Report

    Report Number
    3005471919-2017-00011
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 22, 2017
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    PMA / PMN Number
    K072539
    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 STATES HE IS NOT SPECIFICALLY CLAIMING THAT THE CATHETERS CAUSED HIS UTI, BUT HE NOTICED A FEW DAYS AFTER USE THAT HE DEVELOPED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921428 CURE CATHETER URINARY CATHETER EZD CURE MEDICAL LLC M14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other