BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATH DOVR/SIL 2 WY 16F 5CC 2000

    MDR report key: 5846121 · Received August 1, 2016

    Report

    Report Number
    MW5063831
    Event Type
    Injury
    Date Received
    August 1, 2016
    Date of Event
    July 31, 2016
    Report Date
    August 1, 2016
    Manufacturer
    KENDALL/COVIDIEN
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD FOLEY CATHETER 16F PLACED WHILE IN THE OPERATING ROOM. ABOUT 8 HOURS LATER, STAFF RECOGNIZED URINE OUTPUT WAS LOW FOLLOWING SURGERY AS WELL AS THE PATIENT WAS EXPERIENCING A CONSIDERATE AMOUNT OF ABDOMINAL PAIN. FOLEY CATHETER WAS DISCONTINUED WITH A NEW ONE PLACED. PATIENT ACTUALLY HAD 1350 ML OF URINE REMOVED FROM HER BLADDER WITH THE PLACEMENT OF THE NEW FOLEY CATHETER. STAFF DISCARDED FOLEY CATHETER THAT MALFUNCTIONED WHILE BEING UTILIZED BY A PATIENT. PATIENT WAS (B)(6) PREGNANT WHEN THIS EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490374 FOLEY CATH DOVR/SIL 2 WY 16F 5CC 2000 TRY CATH FOL DOVR/SIL 2 WAY 16F KOD KENDALL/COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention