BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 3862741 · Received May 27, 2014

    Report

    Report Number
    1049092-2014-00150
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATED IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIRD PARTY MANUFACTURING SITE: (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

    THE NURSE, WHO HAS BEEN TREATING A HOSPICE PATIENT WITH A SACRAL PRESSURE ULCER WITH AQUACEL FOAM FOR TWO WEEKS, REPORTS THAT THE ORIGINAL SIZE OF THE SACRAL PRESSURE ULCER WAS 2CM; STAGE II WITH LIGHT TO MODERATE EXUDATES. OVER THE LAST TWO WEEKS THE WOUND IS NOW STAGE III; MEASURES 6CM WITH MODERATE EXUDATES, AND REDNESS IN THE AREA OF THE FOAM DRESSING WHICH DOES NOT GO BEYOND THE FOAM. LASTLY, IT IS REPORTED THAT PATIENT IS ALERT, ORIENTED BUT MALNOURISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311810 AQUACEL FOAM 79 NAC NAC CONVATEC INC 420626 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention