BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE

    MDR report key: 2211297 · Received August 2, 2011

    Report

    Report Number
    1820334-2011-00401
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 6, 2011
    Manufacturer
    COOK, INC.
    Product Code
    KNT
    PMA / PMN Number
    K043203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ALLERGIC REACTION NOT LISTED IN IFU. (B)(4) REACTION IS NOT LISTED IN IFU. STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A TIGER 2 TUBE WAS PLACED IN THIS PT. THE PT SHOWED AN ALLERGIC REACTION - SKIN IRRITATION AROUND THE MOUTH AND SOME INTERNAL REACTIONS. AS PER COMPLAINT REPORTING FORM: AFTER THE INSERTION OF THE TUBE, THE PT SUFFERED ALLERGIC REACTIONS LIKE RISE IN PULSE, DROP IN BLOOD PRESSURE, SKIN IRRITATION. THE SYMPTOMS WERE GONE AFTER THE REMOVAL OF THE TIGER 2. PT DID NOT GET HARMED PERMANENTLY. THERE WAS NO PERMANENT HARM TO THE PT. NO SECTION OF THE DEVICE REMAINED IN THE PT. NO ADD'L PROCEDURES PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE KNT TUBES, GASTROINTESTINAL KNT COOK, INC. NA 2708082

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other