BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOVER

    MDR report key: 2032722 · Received February 10, 2011

    Report

    Report Number
    2032722
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 10, 2011
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED PAIN WITH AMBULATION, AND THE FOLEY CATHETER WAS NOTED TO BE PULLED OUT. ON INSPECTION, THE BALLOON WAS NOTED TO BE BROKEN AND DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOVER FOLEY CATHETER KOD COVIDIEN * 910736

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES