BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 4029640 · Received August 1, 2014

    Report

    Report Number
    1049092-2014-00363
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    May 7, 2014
    Report Date
    July 11, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. FINAL QUALITY EVAL PERFORMED ON (B)(4) 2014 IS BASED ON THE FOLLOWING REQUIREMENTS: THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, AN INVESTIGATION WAS INITIATED AND CLOSED ON (B)(4) 2014 BY THIRD PARTY MFR, (B)(4), BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, STERILIZATION PROCESS DOCUMENTATION, AND RETAIN SAMPLE FOR THE TEN (10) PREVIOUS LOTS. RESULTS SHOWED NO NON-CONFORMANCES IN THE RAW MATERIALS, MFG, PACKAGING, OR THE STERILIZATION PROCESSES. THIS REPORT IS NOW A PART OF (B)(4) CAPA SYSTEM. (B)(4) WILL CONTINUE TO MONITOR THAT SYSTEM FOR ANY INDICATION OF REPEATABLE REPORTS BY COMPLAINT TYPE AND BY PRODUCT NUMBER. ADD'L QUALITY EVAL STATES THAT THERE WERE FORTY EIGHT (48) REPORTS WITH SIMILAR COMPLAINT FOR APPARENT ALLERGIC REACTION TO THE SILICONE ADHESIVE; EIGHTEEN (18) OF THESE WERE WITHIN THE PAST YEAR. 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. 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 THE REMOVAL OF THE DRESSING, THE PT'S SKIN PRESENTED WITH REDNESS,, BLISTERING AND BLEEDING RESULTING FROM CONTACT WITH PRODUCT'S ADHESIVE RESULTING IN ITS REMOVAL AND REPLACED WITH AN AQUACEL FOAM NON-ADHESIVE DRESSING. IT IS FURTHER REPORTED THAT THE DRESSING WAS IN PLACED FOR SEVEN (7) DAYS AT A TIME FOR FOUR (4) WEEKS WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449540 AQUACEL FOAM HYDROPHILIC WOUND DRESSING NAC CONVATEC, INC. 420680 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention