BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3500944 · Received November 25, 2013

    Report

    Report Number
    3500944
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    November 19, 2013
    Report Date
    November 25, 2013
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    8 FRENCH FOLEY CATHETER IN PLACE, BUT NOT DRAINING. A BLADDER SCAN SHOWED FULL BLADDER; UNABLE TO DEFLATE BALLOON TO REPOSITION. AFTER MUCH DIFFICULTY, BALLOON DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611160 * FOLEY CATHETER NWR MEDLINE INDUSTRIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR