BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER

    MDR report key: 3101578 · Received May 3, 2013

    Report

    Report Number
    1018233-2013-01713
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS FORTHCOMING. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUFF ROLL WAS NOTED ON THE BALLOON UPON CATHETER REMOVAL. NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194503 FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1