BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1

    MDR report key: 1053034 · Received May 15, 2008

    Report

    Report Number
    1053034
    Event Type
    Malfunction
    Date Received
    May 15, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 15, 2008
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON RUPTURE WITH INITIAL INSERTION AND INFLATION OF THE BALLOON. IT WAS INFLATED ACCORDING TO SPECIFICATIONS PER KIT INSTRUCTIONS. SECOND CATHETER INSERTED; SAME RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 CATHETER, FOLEY KOD SMITHS MEDICAL ASD INC. 16 FR 669005

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR