BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL EXTRA

    MDR report key: 3915431 · Received February 25, 2014

    Report

    Report Number
    1000317571-2014-00010
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPOTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. IT WAS CONFIRMED THE PRODUCT WAS NOT USED ON THE PT. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC'S INC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    INFO RECEIVED VIA COMPLAINT FORM IS INDICATED AS FOLLOWS: "THE DRESSING (INNER) PACKAGE WAS OPEN. NON STERILE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115506 AQUACEL EXTRA HYDROPHILLIC WOUND DRESSING NAC CONVATEC LIMITED 420673 3F02180

    Patients

    Seq Age Sex Outcome Treatment
    1