BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE CONVEX 1 PC PRE-CUT DRAINABLE POUCH W/DURAHESIVE SKIN BARRIER

    MDR report key: 4132828 · Received September 29, 2014

    Report

    Report Number
    1049092-2014-11750
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    June 17, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    EXB
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED (B)(6) 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    PATIENT REPORTED A SKIN RASH DUE TO THE LARGER SIZE OF THE PRECUT OPENING LOCATED IN THE EXTRA SPACE BETWEEN THE STOMA AND THE MASS. THE SKIN IS EXCORIATED WITH A SLIGHT PAINFUL FEELING. PATIENT CHANGED HIS POUCH DAILY AND REPORTED DAILY SHOWERS. THE AREA IS CLEANSED WITH WARM WATER AND LIQUID SOAP. THE END USER SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607178 ACTIVELIFE CONVEX 1 PC PRE-CUT DRAINABLE POUCH W/DURAHESIVE SKIN BARRIER POUCH OSTOMY EXB CONVATEC INC. 175779 2L01069

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other