BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA INVISI STD TAN BSF 45MM

    MDR report key: 5155687 · Received October 16, 2015

    Report

    Report Number
    9618003-2015-30635
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOM. REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (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

    CUSTOMER REPORTS THE OUTLET CLOSURE IS ROUGH AND UNEVEN, NOTED PRIOR TO USE THE PRODUCT. HE ALSO REPORTS THE SEAM IS NOT WELDED BEYOND THE OUTLET STRIP CREATING A GAP ON END USER LEFT SIDE APPROXIMATELY 1-3MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685792 NATURA INVISI STD TAN BSF 45MM POUCH, COLOSTOMY EZQ CONVATEC DOM. REPUBLIC INC 413334 4G00485

    Patients

    Seq Age Sex Outcome Treatment
    1