BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE 1 PC CLOSED END POUCH

    MDR report key: 3950778 · Received June 9, 2014

    Report

    Report Number
    9618003-2014-00057
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE DEVICE WAS USED BY AN END USER, HOWEVER, NO HARM TO THE END USER WAS REPORTED. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED.

    Description of Event or Problem · 1

    AN END USER REPORTED STOOL IS NOT MOVING DOWN INTO THE OSTOMY POUCH DUE TO A "FLAT BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334501 ACTIVELIFE 1 PC CLOSED END POUCH POUCH, COLOSTOMY EZQ CONVATEC INC 062446 CNO

    Patients

    Seq Age Sex Outcome Treatment
    1