BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 4217374 · Received October 14, 2014

    Report

    Report Number
    1036445-2014-00008
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 11, 2014
    Report Date
    October 10, 2014
    Manufacturer
    WELL LED MEDICAL
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS OBSTRUCTED AND SURGERY HAD TO BE PERFORMED TO REMOVE IT FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651966 FOLEY CATHETER CATHETER EZL WELL LED MEDICAL 7-6505-18 1309011420

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention