BEUDAMED
    FDA Adverse Event Summary report: N

    FOLY CATH 100% SLCON 30CC 20FR

    MDR report key: 484968 · Received September 15, 2003

    Report

    Report Number
    1282497-2003-00028
    Date Received
    September 15, 2003
    Date of Event
    March 1, 2002
    Report Date
    March 7, 2002
    Manufacturer
    THE KENDALL CO.
    Product Code
    EZL
    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 ER FOR REMOVAL. SPOKE WITH THE CUSTOMER IN 03/02 AND THE BALLOON RUPTURED ON THE SECOND CATHETER. CUSTOMER HAD A UROSCOPIC PROCEDURE TO REMOVE THE FRAGMENTS. KENDALL NOTIFIED OF THE OCCURRENCE IN 03/02.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other