BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC DRAINABLE POUCH W/ STOMAHESIVE

    MDR report key: 4100694 · Received September 12, 2014

    Report

    Report Number
    9618003-2014-00085
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 26, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. END USER REPORTS CURRENTLY APPLYING STOMAHESIVE POWDER AND AN UNK PROTECTIVE SKIN BARRIER WIPE. END USER WAS INSTRUCTED IN SKIN CARE AND TO CONTINUE WITH THE CRUSTING AND IF THE RASH DOES NOT GO AWAY TO CONSULT HER PHYSICIAN FOR AN ANTIFUNGAL POWDER. END USER WILL BE SENT SAMPLES OF THE ESTEEM PLUS ONE PIECE APPLIANCE. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. (B)(4).

    Description of Event or Problem · 1

    END USER REPORTS DEVELOPING A RED RAISED BUMPY SOMETIMES ITCHY RASH UNDER HER WAFER ON (B)(6) 2014. THIS RASH IS LOCATED UNDER THE MASS ONLY AND DOES NOT EXTEND TO THE TAPE COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565152 ACTIVELIFE 1 PC DRAINABLE POUCH W/ STOMAHESIVE POUCH, COLOSTOMY EZQ CONVATEC, INC. 022771 4F00698

    Patients

    Seq Age Sex Outcome Treatment
    1 Female