BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENDALL DOVER

    MDR report key: 651796 · Received December 8, 2005

    Report

    Report Number
    1282497-2005-00030
    Event Type
    Other
    Date Received
    December 8, 2005
    Date of Event
    June 9, 2005
    Report Date
    June 23, 2005
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    EZL
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE IN 2005, THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. THE CUSTOMER ALLEGES THAT THE CATHETER WAS FOUND IN THE PATIENT'S BED TWO HOURS AFTER BEING FITTED; THE BALLON HAD DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL DOVER SILICONE FOLEY CATHETER 18FR EZL TYCO HEALTHCARE/KENDALL NA 100402

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other