BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL

    MDR report key: 1081410 · Received July 23, 2008

    Report

    Report Number
    MW5007783
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 20, 2008
    Report Date
    July 23, 2008
    Manufacturer
    TYCO HEALTHCARE GROUP
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT'S CAREGIVER CHANGED THE FOLEY CATHETER DRAINAGE BAG AND THE TUBING FOR URINE TO DRAIN INTO THE BAG WAS NOTED TO BE PERMANENTLY KINKED WHERE THE URINE WOULD DRAIN INTO THE COLLECTION BAG. THE CAREGIVER SAVED THE INFO FOR ME TO REPORT AS I AM THE PT'S WEEKLY VISITING HOME CARE NURSE. FORTUNATELY, THE PT HAD AN EXTRA COLLECTION BAG, AS THE DME SUPPLY CO HAS BEEN RATIONING HER SUPPLIES. THE PT IS A QUADRIPLEGIC AND REQUIRES AN ONGOING FOLEY CATHETER FOR URINARY ELIMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL DRAINAGE BAG EYZ TYCO HEALTHCARE GROUP MONO FLO 814050864

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR