BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURITY 100% SILICONE FOLEY CATHETER

    MDR report key: 320309 · Received March 9, 2001

    Report

    Report Number
    9610849-2001-00008
    Event Type
    Other
    Date Received
    March 9, 2001
    Report Date
    March 8, 2001
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO REMOVE FOLEY CATHETER. BALLOON WOULD NOT DEFLATE, CUT FOLEY IN HALF TO GET WATER OUT. BALLOON REMAINED INFLATED. PHYSICIAN CALLED UROLOGY. TEAM WORKED WITH FOLEY. MD'S COULD NOT DEFLATE BALLOON. MD'S FORCED FOLEY OUT WITH BALLOON INTACT CAUSING BLEEDING TO PT. KENDALL NOTIFIED ON 02/28/01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10517 CURITY 100% SILICONE FOLEY CATHETER CATHETER EZL THE KENDALL COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other