BEUDAMED
    FDA Adverse Event Other Summary report: N

    16 FR. ULTRAMER FOLEY TRAY

    MDR report key: 477575 · Received August 11, 2003

    Report

    Report Number
    9612030-2003-00002
    Event Type
    Other
    Date Received
    August 11, 2003
    Date of Event
    July 15, 2003
    Report Date
    August 11, 2003
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 07/22/03, THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. THE CUSTOMER REPORTS, "THE CATHETER WOULD NOT DEFLATE, AND THEREFORE HAD TO BE SURGICALLY REMOVED FORM THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16 FR. ULTRAMER FOLEY TRAY FOLEY CATHETER EZL TYCO HEALTHCARE/KENDALL * 373010

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other