BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX FOLEY CATHETER

    MDR report key: 130201 · Received November 4, 1997

    Report

    Report Number
    MW1012419
    Event Type
    Malfunction
    Date Received
    November 4, 1997
    Date of Event
    November 3, 1997
    Report Date
    November 4, 1997
    Manufacturer
    C.R. BARD, INC-UROLOGICAL DIVISION
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON ON 8FR CATHETER LEAKED UPON TESTING. THE PRODUCT WAS REPLACED WITH NO KNOWN PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX FOLEY CATHETER URINARY CATHETER KOD C.R. BARD, INC-UROLOGICAL DIVISION * 39EHB059

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other