BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOLY CATH 100% SLCON 30CC 20FR

    MDR report key: 381976 · Received March 7, 2002

    Report

    Report Number
    1282497-2002-00004
    Event Type
    Other
    Date Received
    March 7, 2002
    Date of Event
    March 1, 2002
    Report Date
    March 7, 2002
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TWO ALLEGED RUPTURED FOLEY CATHETER BALLOONS. PUTS ONLY 23CC IN THE 30CC BALLOON. THE FIRST CATHETER COULD BE REMOVED BY THE CUSTOMER. THE SECOND RUPTURED ACCORDING TO THE CUSTOMER, BUT COULD NOT BE REMOVED. CUSTOMER TOLD TO GO TO THE EMERGENCY ROOM FOR REMOVAL. SPOKE WITH THE CUSTOMER AFTER THE EVENT AND THE BALLOON RUPTURED ON THE SECOND CATHETER. CUSTOMER HAD A UROSCOPIC PROCEDURE TO REMOVE THE FRAGMENTS. KENDALL NOTIFIED OF THE OCCURENCE IN 03/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLY CATH 100% SLCON 30CC 20FR * EZL THE KENDALL COMPANY * 0097019, 9356019

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other