BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FOLEY CATHETER

    MDR report key: 3874848 · Received April 25, 2014

    Report

    Report Number
    1018233-2014-00092
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED TRAUMA AND BLEEDING DUE TO CUFFING OF THE CATHETER UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250704 SILICONE FOLEY CATHETER UNK EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1