BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIRCON XL 3000 AIR CONTRAST KIT 3L

    MDR report key: 496365 · Received November 12, 2003

    Report

    Report Number
    9610849-2003-00001
    Event Type
    Other
    Date Received
    November 12, 2003
    Report Date
    November 11, 2003
    Manufacturer
    NELLCOR/TYCO HEALTHCARE
    Product Code
    FCE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SOMETIME LAST WEEK, A ROUTINE BARIUM ENEMA WAS PERFORMED ON A PT. THE RETENSION CUFF WAS BLOWN UP AND SOMETIME DURING THE PROCEDURE, BROKE WHILE IN THE PT. THE BALLOON WAS STILL ATTACHED TO THE TIP AND WAS REMOVED. THE PT SUFFERED NO ADVERSE EFFECT FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRCON XL 3000 AIR CONTRAST KIT 3L ENEMA KIT W/ SILICONE RETENTION CUFF FCE NELLCOR/TYCO HEALTHCARE * 3195060

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other