BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD CATHETER FOLEY SILVER CBI, 16F

    MDR report key: 2057651 · Received April 8, 2011

    Report

    Report Number
    MW5020238
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    UROLOGICAL BARD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH FOLEY CATHETER FOR BLADDER SPASMS. HEARD A POP SOUND AND HAD IMMEDIATE PAIN IN PENIS. BLOOD NOTED IN URINE. ATTEMPTS TO IRRIGATE FOLEY AND DEFLATE BALLOON UNSUCCESSFUL. FOLEY REMOVED INTACT EXCEPT FOR THE BALLOON WHICH WAS MISSING OFF THE CATHETER. PT LATER AVOIDED AND BALLOON FRAGMENT WAS IN THE URINE. DATES OF USE: (B)(4) 2011 - (B)(4) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD CATHETER FOLEY SILVER CBI, 16F FOLEY CATHETER KOD UROLOGICAL BARD U04990

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other