BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION PRM 16FR CATH SECURE

    MDR report key: 2565801 · Received May 3, 2012

    Report

    Report Number
    9612030-2012-00023
    Event Type
    Other
    Date Received
    May 3, 2012
    Date of Event
    March 17, 2012
    Report Date
    April 4, 2012
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 05/02/2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 04/04/2012 THAT A CUSTOMER HAD AN ISSUE WITH A PRECISION FOLEY CATHETER. THE CUSTOMER REPORTED THAT A PT ATTEMPTED TO REMOVE HIS FOLEY CATHETER WHEN THE TUBING BROKE, LEAVING A 23.5 CM LENGTH OF THE TUBING IN HIS BLADDER/URETER. THE TUBING WAS REMOVED BY CYSTOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION PRM 16FR CATH SECURE FOLEY CATHETER KOD COVIDIEN PP16SD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention