BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA CATHETER

    MDR report key: 9781582 · Received March 3, 2020

    Report

    Report Number
    3005471919-2020-00009
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    February 2, 2020
    Report Date
    March 3, 2020
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    KOD
    UDI-DI
    00815947020437
    PMA / PMN Number
    K080881
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT (USER) REPORTED SHE IS SENSITIVE TO THE LUBRICANT AND HAS BEEN WIPING IT OFF THE CATHETERS BEFORE USING THEM. COINCIDING WITH CATHETER USE THE PATIENT ACQUIRED A URINARY TRACT INFECTION. SHE HAS BEEN PRESCRIBED AN ANTIBIOTIC AND FEELS BETTER NOW BUT SHE IS STILL TAKING IT (A 10 DAY COURSE). PATIENT IS CHANGING TO A CATHETER THAT IS NOT PRE-LUBRICATED AND PLANS TO APPLY HER OWN LUBRICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244158 ULTRA CATHETER URINARY CATHETER KOD CURE MEDICAL LLC ULTRA12 190312-2 00815947020437

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other