BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM PCH CLD WF STDTAN 60/70MM

    MDR report key: 5154347 · Received October 15, 2015

    Report

    Report Number
    9618003-2015-30598
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    August 20, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOM. REPUBLIC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    END USER REPORTS CHANGES POUCH THREE TIMES A DAY. REPORTS STOMAHESIVE SHREDS AND IS HARD TO REMOVE EVEN WITH ADHESIVE REMOVER. USES SENSICARE SKIN PROTECTANT BARRIER WIPES. REPORTS WHEN PRODUCT DELIVERED BOXES WERE WARM TO TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683759 ESTEEM PCH CLD WF STDTAN 60/70MM POUCH, COLOSTOMY EZQ CONVATEC DOM. REPUBLIC 416701 4G00844

    Patients

    Seq Age Sex Outcome Treatment
    1