BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM 1 PC-DRAINABLE INVISCLOSE POUCH

    MDR report key: 3883648 · Received June 9, 2014

    Report

    Report Number
    9618003-2014-00056
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER STATED SHE IS USING (B)(4) POWDER BLOTTED WITH SENSICARE STING FREE BARRIER WIPE AND (B)(4) SLIM. THE END USER WAS ALSO EDUCATED ON PROPER SKIN CARE. THE END USER CONFIRMED THAT THE PRODUCT LOT NUMBER IS NOT AVAILABLE. THE END USER WAS SENT A REPLACEMENT OF THE ESTEEM PLUS CONVEX FOR TRIAL AND WAS ALSO ENCOURAGED TO FOLLOW-UP WITH HER HEALTH CARE PROVIDER IF CONCERNS PERSIST OR WORSEN. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED.

    Description of Event or Problem · 1

    AN END USER REPORTED HER PERISTOMAL SKIN IS RED, OPEN, WEEPY AND ITCHY UNDER THE TAPE COLOR. THE END USER STATED SHE WAS EVALUATED BY HER GENERAL PRACTITIONER APPROXIMATELY 3 WEEKS AGO. THE DOCTOR PRESCRIBED TOPICAL (B)(6) POWDER TO BE APPLIED TO THE PERISTOMAL SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334189 ESTEEM 1 PC-DRAINABLE INVISCLOSE POUCH POUCH, COLOSTOMY EZQ CONVATEC INC. 416976 CNO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention