BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL

    MDR report key: 1569909 · Received December 30, 2009

    Report

    Report Number
    1569909
    Event Type
    Malfunction
    Date Received
    December 30, 2009
    Date of Event
    December 9, 2009
    Report Date
    December 15, 2009
    Manufacturer
    COVIDIEN
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLEY INSERTED POST EPIDURAL. HUNG AT FOOT OF BED AND LEAKED ON FLOOR. VALVE IN CLOSED POSITION. VALVE OPENED AND CLOSED AND STILL LEAKING. THE MFR OF THIS PRODUCT IS KENDALL. THE CATALOG # 6146LL, THE LOT# 916755764.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL FOLEY CATHETER DRAINAGE BAG EYZ COVIDIEN UNK 916755764

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other