BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE

    MDR report key: 3848665 · Received May 21, 2014

    Report

    Report Number
    9618003-2014-00047
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER STATED A PHYSICIAN PRESCRIBED SILVER SULFADIAZINE CREAM TO USE TOPICALLY ON HIS PERISTOMAL SKIN. THE END USER STATED HE USES ADHESIVE REMOVER, (B)(6) SOAP, POWDER, AND A BARRIER WIPE. THE END USER ALSO STATED HE IS CUTTING THE MASS LARGER TO FIT HIS STOMA. SUGGESTED THAT CUSTOMER TRIAL PRODUCT WHICH ACCOMMODATES LARGER STOMA AND HE DECLINED. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED A RETURN SAMPLE FOR EVALUATIONS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    AN END USER REPORTED BLISTERS ON HIS PERISTOMAL SKIN UNDER A PORTION OF THE WAFER AND A PORTION OF THE TAPE COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303018 ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE POUCH, COLOSTOMY EZQ CONVATEC INC. 022770 3H02898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention