BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPAT 22 FR BALLOON G-TUBE

    MDR report key: 1023732 · Received March 27, 2008

    Report

    Report Number
    2110851-2008-00003
    Event Type
    Other
    Date Received
    March 27, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 25, 2008
    Manufacturer
    NESTLE HEALTHCARE NUTRITION
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFO WITH THE EXCEPTION OF THE PATIENT'S SEX IS AVAILABLE AT THIS TIME. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    COMPAT BALLOON FAILED DURING USE WHILE IN PT. NO INTERVENTION WAS REQUIRED PER THE CARE GIVER, AND IT IS UNKNOWN WHO REMOVED AND REPLACED THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT 22 FR BALLOON G-TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT NESTLE HEALTHCARE NUTRITION 087442 0966H

    Patients

    Seq Age Sex Outcome Treatment
    1