BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 3884083 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00191
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    January 13, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO SAMPLE WAS AVAILABLE FOR EVAL; HOWEVER, AN INVESTIGATION WAS PERFORMED ON 06/06/2014 BY THE THIRD PARTY MFR, (B)(4), BASED ON THE REVIEW OF DEVICE HISTORY RECORDS, STERILIZATION RECORDS, AND RETAIN SAMPLES OF THE TEN (10) PREVIOUS PRODUCTION BATCHES. RESULTS SHOWED NO NON-CONFORMANCES DURING THE MFG, PACKAGING AND STERILIZATION PROCESSES FOR THIS LOT, AND NO EVIDENCE INDICATED A MFG ERROR OCCURRED. A VERY LIMITED NUMBER OF PEOPLE EXHIBIT ALLERGIC REACTIONS TO SILICONE ADHESIVES ARE RECEIVED WITH IN ACCORDANCE WITH PROCEDURE WCL.QLP.020, AND HAVE ACCOMPANYING CERTIFICATE OF CONFORMANCE AND/OR CERTIFICATE OF ANALYSIS AND THE AQUACEL FOAM IS REPORTED TO HAVE BEEN MANUFACTURED USING MEDICAL GRADE RAW MATERIALS THAT HAVE BEEN APPROVED FOR SKIN CONTACT UNDER CGMP CONTROLLED CONDITIONS IN AN ISO CLASS 8 CLEAN ROOM. PACKAGING COMPONENTS ARE TESTED "PRE STERILE" FOR SEAL INTEGRITY. IN CONCLUSION, THIS IS PART OF (B)(4) CAPA SYSTEM AND THEY HAVE INDICATED THEY WILL CONTINUE TO MONITOR FOR ANY INDICATION OF REPEATABLE RECORDS BY COMPLAINT TYPE AND PRODUCT NUMBER, AND WILL REVIEW THE DATA TO EVALUATE TRENDS RELATING TO CUSTOMER COMPLAINTS. REPORTED TO FDA ON JUNE 09, 2014. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT EXPERIENCED AN ALLERGIC REACTION FROM THE AQUACEL FOAM DRESSING AS IDENTIFIED BY THE TREATING PODIATRIST WHO REPORTED THAT "SHE FELT IT WAS AN ALLERGIC REACTION". THE PODIATRIST APPLIED AQUACEL FOAM ADHESIVE HEEL DRESSING TO WOUND ON RIGHT HEEL ON FRIDAY (B)(6) 2014, THE PT REMOVED THE DRESSING ON MONDAY (B)(6) 2014 AND THE AREA UNDERNEATH THE SILICONE ADHESIVE WAS RED AND EXCORIATED. PT ALSO HAD AN ALLEVYN ADHESIVE DRESSING ELSE WHERE ON HER BODY; THEREFORE, A DECISION WAS TAKEN TO DISCONTINUE AQUACEL FOAM AND REPLACE WITH ALLEVYN ADHESIVE INSTEAD. LASTLY, IT IS REPORTED THAT PT'S SKIN RETURNED TO NORMAL CONDITION "WITHIN A FEW DAYS", AND WAS ABLE TO USE AQUACEL WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334433 AQUACEL FOAM HYDROPHILIC WOUND DRESSING, 79NAC NAC CONVATEC INC. 420625 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention