BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L3C0600 - CURE PRODUCTS

    MDR report key: 13653227 · Received March 2, 2022

    Report

    Report Number
    1049092-2022-00069
    Event Type
    Injury
    Date Received
    March 2, 2022
    Report Date
    February 1, 2022
    Manufacturer
    CONVATEC INC
    Product Code
    EZD
    UDI-DI
    00815947021069
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    END USER REPORTS "INTERMITTENT URINARY SELF-CATHETERIZATION 2-4XDAY FOR THE PAST 5 YEARS. HE WAS USING CURE M14 AND HR LUBRICANT WITHOUT ISSUE. WHEN HE SWITCHED INSURANCE AND RETAILERS HE WAS OFFERED A PRE-LUBRICATED CATHETER ULTRAM14 WHICH HE STARTED TO USE ON (B)(6) 2022." END USER REPORTS "BURNING FEELING TO THE URETHRA WITH CATHETERIZATION AND VOIDING. ISSUE STARTED 1 WEEK AFTER STARTING TO USE THIS CATHETER. HE REPORTED THE ISSUE TO HIS DOCTOR WHO DID A URINE CULTURE AND HE WAS FOUND TO HAVE A URINARY TRACT INFECTION UTI RE: BACTERIAL INFECTION. HE WAS GIVEN ORAL ANTIBIOTICS INCLUDING CIPRO AND LEVAQUIN. THE SYMPTOMS HAVE RESOLVED. END USER ATTRIBUTES THE ISSUE TO THE LUBRICATION ON THE CATHETER." END USER REPORTS 30 CATHETERS HOWEVER IT IS UNKNOWN HOW MANY CATHETERS ARE ASSOCIATED WITH THE UTI. THIS CASE IS TO CAPTURE THE UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953885 L3C0600 - CURE PRODUCTS EZD CONVATEC INC 510814 00815947021069

    Patients

    Seq Age Sex Outcome Treatment
    1 Male