BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16FR SILVER DRAIN BAG FOLEY TR

    MDR report key: 1425200 · Received April 22, 2009

    Report

    Report Number
    9612030-2009-00015
    Event Type
    Malfunction
    Date Received
    April 22, 2009
    Date of Event
    December 19, 2007
    Report Date
    December 20, 2007
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 04/21/2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN LATE 2007 THAT A CUSTOMER HAD A PROBLEM WITH A URINARY CATHETER. THE CUSTOMER STATED THAT THE BALLOON ON THE CATHETER WOULD NOT DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16FR SILVER DRAIN BAG FOLEY TR URINARY CATHETER KOD COVIDIEN 6146ICLL 732058464

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK