BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

    MDR report key: 3915740 · Received June 12, 2014

    Report

    Report Number
    1018233-2014-00150
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 19, 2014
    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
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE 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 UPON REMOVAL THE BALLOON FORMED A CUFF AND CAUSED BLEEDING AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346673 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1