BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 3892057 · Received June 10, 2014

    Report

    Report Number
    1049092-2014-00208
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    NAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. QUALITY EVAL PERFORMED ON (B)(6) 2014 STATED THAT THERE ARE 43 SIMILAR COMPLAINTS NOTED FOR IRRITATION UNDER THE ADHESIVE. THE LOT NUMBER WAS NOT AVAILABLE FOR REFERENCE. NO SAMPLE WAS AVAILABLE FOR EVAL; HOWEVER, AN INVESTIGATION WAS PERFORMED ON (B)(6) 2014 BY THE MFR, (B)(4), BASED ON THE REVIEW OF RAW METRIAL RECEIVING RECORDS, DEVICE HISTORY RECORDS, AND STERILIZATION RECORDS FOR TEN (B)(4) PREVIOUS PRODUCTION BATCHES. RESULTS SHOWED NO NON-CONFORMANCES DURING THE MFG, PACKAGING OR STERILIZATION. IN RARE CASES ALLERGIC REACTIONS TO SILICONE GELS HAVE BEEN REPORTED ACCORDING TO THE SILICONE SUPPLIER. CONCLUSION/ROOT CAUSE: THIS PRODUCT IS MANUFACTURED USING MEDICAL GRADE RAW MATERIALS THAT HAVE BEEN APPROVED FOR SKIN CONTACT. ALL RAW MATERIALS ARE RECEIVED IN ACCORDANCE WITH (B)(4), AND HAVE ACCOMPANYING CERTIFICATE OF ANALYSIS AND CERTIFICATE OF CONFORMANCE. MFG IS PERFORMED IN AN ISO CLASS 8 CLEAN ROOM AND IN ACCORDANCE TO CGMP CONDITIONS. PACKAGING COMPONENTS ARE TESTED "PRE STERILE" FOR SEAL INTEGRITY. IN CONCLUSION, THIS IS PART OF(B)(4)'S CAPA SYSTEM AND THEY HAVE INDICATED THEY WILL CONTINUE TO MONITOR FOR ANY INDICATION OF REPEATABLE RECORDS BY COMPLAINT TYPE AND PRODUCT NUMBER, ADN WILL REVIEW THE DATA TO EVAL TRENDS RELATING TO CUSTOMER COMPLAINTS. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. REPORTED TO THE FDA ON (B)(4) 2014. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MFG SITE: 2320643. (B)(4). CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATECS INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT WITH A PRESSURE ULCER EXPERIENCED FLUID-FILLED BLISTERS IN THE AREA OF THE SILICONE ADHESIVE. THE INITIAL DRESSING CHANGE WERE DONE WITH MEPILEX, HOWEVER, THERE WAS AN ORDER TO USE THE AQUACEL FOAM FOR THE DRESSING CHANGE. THE NURSE USED MEPILEX ORIGINALLY AND TRIED AQUACEL FOAM ACCORDING TO DOCTOR'S ORDERS. UPON REMOVAL OF THE DRESSING, NURSE NOTICED SEVERAL BLISTERS RESULTING IN SWITCHING BACK TO USING THE ORIGINAL MEPILEX DRESSING. IT IS REPORTED THAT THE BLISTERS RESIDED WHILE USING MEPILEX, AND THAT NO MEDICATION WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343398 AQUACEL FOAM HYDROPHILIC WOUNDDRESSING NAC CONVATEC INC 420680 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention