BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT SILICONE FOLEY CATHETER

    MDR report key: 8608287 · Received May 13, 2019

    Report

    Report Number
    MW5086608
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 9, 2019
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLEY KIT LEAKING URINE AT LUER LOCK VALVE SITE TO DRAINAGE TUBE POST FOLEY INSERTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399783 SELECT SILICONE FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL MEDLINE INDUSTRIES, INC. 19DBK076

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR