BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERASE CAUDI

    MDR report key: 3513835 · Received November 15, 2013

    Report

    Report Number
    3513835
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    November 14, 2013
    Report Date
    November 15, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLEY CATHETER WOULD NOT INFLATE - PHYSICIAN HAD TO CUT CATHETER AND VERY SLOWLY DEFLATED.====================== MANUFACTURER RESPONSE FOR FOLEY CATHETER, FOLEY CATHETER TRAY (PER SITE REPORTER).====================== THANK YOU FOR BRINGING THIS TO OUR ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593774 ERASE CAUDI FOLEY CATHETER NWR MEDLINE INDUSTRIES, INC * 13IB4058

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR