BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICON FOLEY CATHETER

    MDR report key: 406934 · Received July 19, 2002

    Report

    Report Number
    1282497-2002-00017
    Event Type
    Other
    Date Received
    July 19, 2002
    Date of Event
    June 9, 2002
    Report Date
    June 26, 2002
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 06/2002 THAT THERE HAD BEEN A PROBLEM WITH A FOLEY CATHETER LESS THAN 24 HOURS AFTER INSERTION. ACCORDING TO THE SUBMITTED REPORT THE CATHETER FELL OUT OF THE PATIENT. THE CUSTOMER STATES THAT THE CATHETER WAS DEFECTIVE BECAUSE THE BALLOON WOULD NOT HOLD FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICON FOLEY CATHETER URINARY CATHETER EZL TYCO HEALTHCARE/KENDALL * 101524

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization