BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL FOAM

    MDR report key: 4023882 · Received July 14, 2014

    Report

    Report Number
    1049092-2014-00297
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE DEVICE WAS USED BY AN END USER, HOWEVER, NO HARM TO THE END USER WAS REPORTED. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. (B)(4). 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 THERE IS MOLD ON THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410306 AQUACEL FOAM HYDROPHILIC WOUND DRESSING, 79 NAC NAC CONVATEC, INC. 420680 2231339

    Patients

    Seq Age Sex Outcome Treatment
    1