BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG-ANTIMICROBIAL HYDROFIBER DRESSING

    MDR report key: 3894299 · Received February 19, 2014

    Report

    Report Number
    1000317571-2014-00009
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 22, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K013814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION AS THE ISSUE WAS FOUND PRIOR TO PRODUCT USE. IT IS REPORTED THAT THREE EMAIL REQUESTS WERE SENT TO CLARIFY WHETHER THE COMPLAINANT IS THE SALES REP FOR CONVATEC OR IF THE INFO WAS RECEIVED BY THE SALES REP FROM ANOTHER PARTY. NO RESPONSE RECEIVED TO DATE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFO RECEIVED VIA COMPLAINT FORM IS REPORTED AS FOLLOWS: INFO RECEIVED VIA COMPLAINT FORM IS REPORTED AS FOLLOWS: PACKING PRESSURE SIDE NOT FIRM, PRESSED DRESSING ON THE EDGE OF THE PACKAGING CAUSED POLLUTION OF THE EDGE OPENING MAKES DRESSING CHANGE COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104365 AQUACEL AG-ANTIMICROBIAL HYDROFIBER DRESSING DRESSING, WOUND, DRUG FRO CONVATEC LIMITED 403740 3F01474

    Patients

    Seq Age Sex Outcome Treatment
    1