BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACELAG-ANTIMICROBIAL AG HYDROFIBER DRESSING

    MDR report key: 3899096 · Received May 16, 2014

    Report

    Report Number
    1000317571-2014-00027
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K013814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    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. SIGNED AND DATED COMPLAINT FORM HAS BEEN REQUESTED. THIS CASE WAS EVALUATED ON (B)(6) 2014 AS PER CONVATEC'S GOVERNING COMPLAINT AND HANDLING PROCEDURE AND A VALID INVESTIGATION WAS IDENTIFIED FOR THIS COMPLAINT ISSUE. CASE CLOSED TO CAPA, THIS INVESTIGATION IS ONGOING AND THE NEED FOR CORRECTIVE ACTIONS WILL BE ASSESSED AS PART OF THIS INVESTIGATION. IN CONCLUSION, COMPLAINT SAMPLE WAS NOT RETURNED AND INITIAL INVESTIGATION IS NO CONCLUSIVE. 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. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    DETAILS OF THE COMPLAINT IS AS FOLLOWS: "SEVERAL BLACK SPOTS ON THE DRESSING WHEN OPENED, THEY LOOK LIKE MOLD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293628 AQUACELAG-ANTIMICROBIAL AG HYDROFIBER DRESSING DRESSING, WOUND, DRUG FRO CONVATEC LIMITED 403711 3E00133

    Patients

    Seq Age Sex Outcome Treatment
    1