BEUDAMED
    FDA Adverse Event Summary report: N

    16 FR. ULTRAMER FOLEY TRAY

    MDR report key: 380694 · Received March 4, 2002

    Report

    Report Number
    9612030-2002-00001
    Date Received
    March 4, 2002
    Date of Event
    February 4, 2002
    Report Date
    March 4, 2002
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER HAS EXPERIENCED A NON-DEFLATOR. ONE PT HAD THE CATHETER PULLED OUT WITH 5CC OF WATER STILL IN THE BALLOON. BALLOON DID NOT DISOLVE WITH MINERAL OIL. KENDALL NOTIFIED ON 02/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16 FR. ULTRAMER FOLEY TRAY * EZL THE KENDALL COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other