BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENDALL DOVER

    MDR report key: 732863 · Received June 27, 2006

    Report

    Report Number
    1282497-2006-00026
    Event Type
    Other
    Date Received
    June 27, 2006
    Date of Event
    June 14, 2006
    Report Date
    June 19, 2006
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON JUNE 19, 2006, THAT A CUSTOMER HAD A PROBLEM WITH A FOLEY CATHETER. THE CUSTOMER REPORTED THAT THE BALLON BURST WITHIN 12 HOURS AFTER THEY STARTED TO USE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL DOVER DOVER SILVER FOLEY 16FR 5CC 2WY EZL TYCO HEALTHCARE/KENDALL NA 716442

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN