BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 4029670 · Received August 1, 2014

    Report

    Report Number
    1049092-2014-00374
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    May 1, 2014
    Report Date
    July 15, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. FINAL QUALITY EVAL PERFORMED ON (B)(6) 2014 IS BASED ON THE FOLLOWING REQUIREMENTS: THE LOT NUMBER 2264713 WAS PROVIDED AND WAS USED TO CONDUCT AN INVESTIGATION INITIATED AND CLOSED ON (B)(6) 2014 FOR THIRD PARTY MFR, (B)(4), BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, STERILIZATION RECORDS, AND RETAIN SAMPLES. RESULTS INDICATED THAT THE RAW MATERIALS MET SPECS, AND SHOWED NO OBSERVATIONS RELATED TO NON-CONFORMANCES DURING THE MFG, PACKAGING, AND THE STERILIZATION PROCESSES. THIS COMPLAINT 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 ELEVEN (11) REPORTS NOTED FOR DRESSING NOT ADHERING SUFFICIENTLY. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PRODUCT WAS APPLIED TO PT'S LEG WOUND CAVITY, AND PACKED WITH AQUACEL EXTRA AND FOAM APPLIED ON TOP. WITHIN TWO (2) TO THREE (3) DAYS OF USE, THE ADHESIVE ROLLED UP RESULTING IN EXUDATE LEAKAGE; IN ADDITION THE PT'S SKIN WAS PULLED AWAY FORMING A BLISTER RESULTING FROM CONTACT WITH THE ADHESIVE PORTION OF THE DRESSING RESULTING IN THE DRESSING BEING DISCONTINUED, AND REPLACED WITH TAGADERM FOAM WHICH SEEMED TO IMPROVE THE SITUATION. ADD'L INFO RECEIVED VIA EMAIL DATED (B)(4) 2014 IS REPORTED AS FOLLOWS: "WHEN THE DRESSING WAS PLACED ON THE SKIN, THE ADHESIVE DID NOT SEEM TO LAST VERY LONG BEFORE THE EDGE WOULD START TO COME AWAY AND ROLL UP MEANING THAT IT WAS NO LONGER ABLE TO ADHERE TO THE SKIN APPROPRIATELY. THIS LED TO MORE FREQUENT DRESSING CHANGES COMPARED TO THE TAGADERM FOAM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451542 AQUACEL FOAM HYDROPHILIC WOUND DRESSING NAC CONVATEC, INC. 420680 2264713

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention