BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 2003529 · Received February 21, 2011

    Report

    Report Number
    MW5019515
    Event Type
    Injury
    Date Received
    February 21, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 21, 2011
    Manufacturer
    BARD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLEY CATHETER DID NOT DEFLATE COMPLETELY FLAT FOR REMOVAL. THERE WAS A SMALL FOLD IN THE AREA WHERE THE BALLOON WAS INFLATED. THIS IS THE SECOND OCCURRENCE BUT ONLY THIS ONE WAS REPORTED. BOTH CATHETERS HAVE THE SAME LOT NUMBER. NEITHER WERE SAVED FOR REVIEW. PTS WERE UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER FOLEY CATHETER KOD BARD NGT1169

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability