BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 3908669 · Received June 4, 2014

    Report

    Report Number
    1049092-2014-00169
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION 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

    IT IS REPORTED THAT WHILE TESTING THE AQUACEL AG DRESSING ON PT'S WOUND THE AQUACEL AG SEPARATED FROM FOAM AND GEL RESIDUE STAYED IN WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327913 AQUACEL FOAM HYDROPHILIC WOUND DRESSING NAC CONVATEC INC. 420642 2249606

    Patients

    Seq Age Sex Outcome Treatment
    1