BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18FR FOLEY UROLOGICAL CATHETER

    MDR report key: 19373400 · Received May 21, 2024

    Report

    Report Number
    MW5155210
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 15, 2024
    Report Date
    May 18, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BALLOON LUMEN RUPTURE ON MEDLINE 18FR FOLEY CATHETER 12 HOURS AFTER INSERTION LEADING TO SUBSEQUENT DISLODGEMENT. PATIENT SELF REINSERTED (B)(6), US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305036 18FR FOLEY UROLOGICAL CATHETER CATHETER, RETENTION TYPE, BALLOON EZL MEDLINE INDUSTRIES, LP - NORTHFIELD 692231006

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other| R