BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM PCH CLD WF STD CLR60/70MM

    MDR report key: 5135814 · Received October 8, 2015

    Report

    Report Number
    9618003-2015-30548
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    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
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD DIFFICULTY REMOVING THE PRODUCT WITHIN IN FEW HOURS OF APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666730 ESTEEM PCH CLD WF STD CLR60/70MM POUCH, COLOSTOMY EZQ CONVATEC DOM. REPUBLIC 416700

    Patients

    Seq Age Sex Outcome Treatment
    1