BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL AG-EXUDATE MANAGEMENT HYDROFIBER

    MDR report key: 3677194 · Received February 28, 2014

    Report

    Report Number
    1000317571-2014-00011
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    NAC
    PMA / PMN Number
    K982116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. IT IS REPORTED THAT THIS HEALTH CARE SETTING USUALLY ONLY USES AQUACEL EXTRA AND THE COMPLAINANT HAS ENSURED THAT ALL AQUACEL AG HAS BEEN DISCONTINUED/REMOVED AND REPLACED WITH AQUACEL EXTRA. QUALITY INVESTIGATION WAS PERFORMED ON (B)(6) 2014 BASED ON THE FOLLOWING REQUIREMENTS: NO RETURNED PRODUCT WAS RECEIVED AT CONVATEC DEESIDE MANUFACTURING PLANT TO ALLOW FOR A FULL INVESTIGATION INTO THE CUSTOMER COMPLAINT. AS PART OF THE MANUFACTURING PROCESS, QUALITY CHECKS ARE REGULAR PREFORMED AND DOCUMENTED. THE BATCH RECORD REVIEW INDICATED THAT ALL REQUIRED IN PROCESS CHECKS AND TESTING WERE CORRECTLY CARRIED OUT. THEREFORE BASED UPON THE EVIDENCE PROVIDED MANUFACTURING PRODUCT MET SPECIFICATION AS PER BATCH RECORD REVIEW. IN ADDITION, THE PRODUCT LOT NUMBER WAS RECORDED AS CNO (COULD NOT BE OBTAIN) INDICATING NO LOT NUMBER WAS AVAILABLE. TWELVE MONTHS OF COMPLAINT HISTORY DATA WAS REVIEWED FOR THIS PRODUCT ICC AS CONVATEC'S GLOBAL COMPLAINT HANDLING PROCEDURE. IN CONCLUSION, BASED ON THE REVIEW, THERE WERE NO OTHER CASES REGISTERED FOR THIS COMPLAINT ISSUE WITH THIS PRODUCT ICC NUMBER WITHIN THE PREVIOUS 12 MONTHS. TRENDS WILL BE MONITORED BY THE COMPLAINTS COMMITTEE. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADDITIONAL INFO IS EXPECTED.

    Description of Event or Problem · 1

    INFO RECEIVED VIA COMPLAINT FORM IS INDICATED AS FOLLOWS: PT HAD AQUACEL DRESSING APPLIED INTO A CAVITY WOUND WHILST IN THEATRE FOLLOWING A CESAREAN SECTION. COMPLAINANT WAS ASKED TO ASSESS THE WOUND AS THE AQUACEL HAD BECOME SO SATURATED THAT IT WAS DISINTEGRATING IN THE WOUND. IT IS REPORTED THAT THE TISSUE VIABILITY NURSE SPENT 45 MINUTES IRRIGATING AND SUCTIONING THE WOUND BED TO REMOVE THE DRESSING, AND PARTIALLY HEALED AREAS OF THE WOUND OPENED UP DURING THIS PROCESS. IT IS REPORTED THAT PRODUCT WAS IN USE FOR TWO (2) DAYS BEFORE THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124770 AQUACEL AG-EXUDATE MANAGEMENT HYDROFIBER HYDROPHILIC WOUND DRESSING NAC CONVATEC LIMITED 177902 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention