BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, ADULT 400 SERIES, 16 FR.

    MDR report key: 1169492 · Received September 18, 2008

    Report

    Report Number
    1221261-2008-00034
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MRI MEDICAL INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION- OTHER: SMITHS MEDICAL IS ANTICIPATING THE RETURN OF THE SAMPLE INVOLVED IN THIS REPORT. UPON RECEIPT OF THE SAMPLE, AND THE COMPLETED INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED. A REVIEW OF OUR COMPLAINTS DATABASE SHOW NO OTHER REPORTS ON THIS DEVICE LOT NUMBER. THIS DEVICE IS MANUFACTURED FOR SMITHS MEDICAL BY MRI MEDICAL INC. THEY HAVE BEEN NOTIFIED OF THIS EVENT.

    Description of Event or Problem · 1

    USER ALLEGES THEY HAD TWO EVENTS OF THE BALLOON BURSTING UPON INFLATION AFTER CATHETER WAS INSERTED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER, ADULT 400 SERIES, 16 FR. 78 KOD CATHETER, UROLOGICAL, SELF-RETAINED KOD MRI MEDICAL INC. 651207

    Patients

    Seq Age Sex Outcome Treatment
    1