BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

    MDR report key: 3820596 · Received April 1, 2014

    Report

    Report Number
    1018233-2014-00070
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Report Date
    March 11, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. A MANUFACTURING REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUFF ROLL WAS NOTED ON THE BALLOON UPON REMOVAL. PATIENT COMPLAINED OF PAIN UPON INSERTION AND REMOVAL. NO INCIDENT OR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196482 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXG0620

    Patients

    Seq Age Sex Outcome Treatment
    1