BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-WAY 5CC ALL-SILICONE FOLEY CATHETER

    MDR report key: 3874658 · Received April 24, 2014

    Report

    Report Number
    1018233-2014-00088
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 2, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UROLOGIST INTERVENTION WAS REQUIRED TO REMOVE THE CATHETER FROM THE PATIENT. THE ISSUE WAS IDENTIFIED AS A RIDGED BALLOON. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE TYPE OF INTERVENTION BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248307 2-WAY 5CC ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1