BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 3951895 · Received July 7, 2014

    Report

    Report Number
    1049092-2014-00268
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CONVATEC, INC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT IS REPORTED THAT THESE PRODUCTS WERE USED ON A TRIAL BASIS BY THE NURSING HOME. IT IS FURTHER REPORTED THAT THE PRODUCT WAS IN USE FOR FOUR DAYS BEFORE THE INCIDENT OCCURRED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 STATES: "I AM GOING TO VIEW THE WOUNDS NEXT THURSDAY PERSONALLY. I ALSO HAD LEFT THEM SOME NON ADHESIVE FOAM, AND WAS ASKED WHICH SIDE GOES AGAINST THE WOUND? THIS WAS REPORTED TO ME AT 3.30 PM FRIDAY (B)(6)." NO ADDITIONAL PATIENT/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. PLEASE NOTE: THERE WERE TWO PATIENTS AFFECTED; THEREFORE, A SEPARATE FDA 3500A FORM HAS BEEN GENERATED TO ADDRESS THE OTHER CASE REPORTED UNDER PATIENT IDENTIFIER(S): (B)(6). MFR REPORT#: 1049092-2014-00268. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE WAS THE DATE CONVATEC BECAME AWARE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES. NO SAMPLE WAS AVAILABLE FOR EVALUATION; HOWEVER, AN INVESTIGATION WAS PERFORMED BY THE THIRD PARTY MANUFACTURER, WEBTEC, INITIATED ON (B)(4) 2014 AND CLOSED ON (B)(4) 2014 BASED ON THE REVIEW OF DEVICE HISTORY RECORDS FOR THIS BATCH, ALONG WITH THE STERILIZATION RUN RECORDS AND RETAIN SAMPLES. RESULTS SHOWED NO NON-CONFORMANCES DURING THE MANUFACTURING, PACKAGING, OR STERILIZATION PROCESS. ALLERGIC REACTIONS TO SILICONE HAVE BEEN NOTED BY THE SILICONE SUPPLIER. CONCLUSION/ROOT CAUSE: AQUACEL FOAM IS MANUFACTURED UNDER CGMP CONTROLLED CONDITIONS IN AN ISO CLASS 8 CLEAN ROOM. ALL PACKAGING MATERIALS ARE TESTED PRE-STERILE TO ENSURE SEAL INTEGRITY. ALL MATERIALS ARE RECEIVED WITH THE SUPPLIERS CERTIFICATE OF CONFORMANCE AND/OR CERTIFICATE OF ANALYSIS. WEBTEC REPORTS THAT THIS IS NOW PART OF THEIR CAPA SYSTEM, AND THEY HAVE INDICATED THAT THEY WILL CONTINUE TO MONITOR THAT SYSTEM FOR ANY INDICATION OF REPEATABLE REPORTS BY COMPLAINT TYPE AND BY PRODUCT NUMBER. ADDITIONAL QUALITY INFORMATION PROVIDED ON (B)(6) 2014 IS AS FOLLOWS: THERE WERE 45 REPORTS NOTED WITH SIMILAR ADHESIVE IRRITATION COMPLAINTS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WITH A "CRITICALLY INFECTED COLONIZED WOUND" OF THE ANKLE, EXPERIENCED A SEVERE REACTION DESCRIBED AS VERY RED RAISED ITCHY SKIN TO THE SILICONE ADHESIVE ON THE FOAM DRESSING AFTER FIRST TIME USE. IT IS FURTHER REPORTED THAT MEPILEX WAS USED IN A PREVIOUS NURSING HOME, WHEN THE PATIENT CAME FROM THE HOSPITAL THEY WERE USING A NON-ADHESIVE DRESSING. THEY SWITCHED TO THE AQUACEL FOAM DRESSING AND THE PATIENT DEVELOPED REDNESS ON THE SKIN UNDER THE ADHESIVE PORTION OF THE DRESSING. AQUACEL SILVER WAS USED DIRECTLY ON THE WOUND THERE WAS NO IRRITATION AT THE WOUND, ONLY WHERE THE ADHESIVE MET THE SKIN. THE EVENT WAS TREATED BY SWITCHING TO THE BORDERLESS FOAM DRESSING AND A CREPE BANDAGE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 STATES: "FURTHER TO THIS COMPLAINT REPORT IS NOW A CLAIM OF MACERATION WHEN USING OUR FOAMS! WHEN I ASKED FURTHER THERE WAS 1-2CM OF SPACE AROUND DRESSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394697 AQUACEL FOAM HYDROPHILIC WOUND DRESSING NAC CONVATEC, INC 420621 2220954

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention