BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL EXTRA

    MDR report key: 3760943 · Received April 14, 2014

    Report

    Report Number
    1000317571-2014-00020
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    February 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    KOZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS AVAILABLE FOR EVALUATION; HOWEVER , AN INVESTIGATION WAS PERFORMED ON 05/07/2014 BY THE THIRD PARTY MANUFACTURER, (B)(4), BASED ON THE REVIEW OF TEN (10) PREVIOUS DEVICE HISTORY RECORDS. RESULTS SHOWED NO MANUFACTURING ERRORS, ISSUES, OR DEFECTS IN THE HISTORY RECORD OR THE RETAINED SAMPLES. ALL RAW MATERIALS WERE RECEIVED WITH THE SUPPLIERS CERTIFICATE OF CONFORMANCE AND/OR CERTIFICATE OF ANALYSIS AND THE AQUACEL FOAM IS 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. WITH NO EVIDENCE TO INDICATE A MANUFACTURING ERROR HAS OCCURRED AND NO SAMPLE OR LOT NUMBER TO REFERENCE, AN INVESTIGATION IS NOT REQUIRED AT THIS TIME. (B)(4) HAS 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. THREE (3) SIMILAR RECORDS NOTED. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY BASED ON THE INFO STATING THE REMOVAL OF THE DRESSING CAUSED BLEEDING, STRIPPING OF SKIN AND PAIN. IT IS REPORTED THAT THERE IS NO REASON FOR THE ADHESION OF 'HIGHLY EXUDING WOUND' COULD BE IDENTIFIED FROM THE INFO PROVIDED. COMPLAINANT FELT THAT THE AQUACEL FOAM HAD DRIED OUT THE AQUACEL EXTRA. IT IS REPORTED THAT THE DEVICE WAS DISCONTINUED BY SPECIALIST, BUT INITIALLY AQUACEL EXTRA HAD BEEN RE-USED WITH NO FURTHER ADHERENCE OR ODOR. CONVATEC'S REPRESENTATIVE DISCUSSED HOW THE TWO PRODUCTS WORK, AND THAT THIS WAS HIGHLY UNLIKELY AS AQUACEL PRODUCTS MAINTAIN THE MOISTURE BALANCE. LASTLY, IT IS REPORTED THAT SINCE THIS ISSUE OCCURRED, THE RESIDENT HAS BEEN REVIEWED BY THE TISSUE VISIBILITY NURSE (TVN) WHO HAS CHANGED THE PRIMARY DRESSING TO INADINE. NO ADD'L PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION 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 IT'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    INFO REC'D VIA COMPLAINT FORM IS INDICATED AS FOLLOWS: UPON USING AQUACEL EXTRA SAMPLES PROVIDED BY (B)(4) REPRESENTATIVE ON CHRONIC LOWER LEG ULCERS OF A PALLIATIVE BED-BOUND RESIDENT, HIS LEG ULCERS LEAKED HIGH LEVELS OF EXUDATE CONSISTENTLY. THEY APPLIED AQUACEL EXTRA AS THE PRIMARY DRESSING WITH AQUACEL FOAM AS THE SECONDARY DRESSING. UPON SMELLING A STRONG MALODOR 48 HOURS LATER, COMPLAINANT ATTEMPTED TO REMOVE THE DRESSING, BUT SHE DID NOT FEEL THAT THE ODOR WAS INDICATIVE OF AN INFECTION AS THE LEGS DID NOT SMELL AND THE ODOR DID NOT RETURN WHEN THE WOUNDS WERE REDRESSED. AS SHE ATTEMPTED TO REMOVE THE AQUACEL EXTRA, SHE FOUND THAT THE DRESSING HAD GELLED AROUND THE EDGES OF THE WOUND, BUT HAD ADHERED TO THE CENTER OF THE WOUND AND HAD BECOME VERY HARD AND DRY. THE ADHERED AQUACEL EXTRA WAS REMOVED AFTER SOAKING FOR 1/2 HOUR WITH SALINE. SHE REPORTED THAT SOME BLEEDING OCCURRED DURING THE PROCEDURE, BUT THAT WAS NOT UNUSUAL FOR THIS WOUND. THE WOUND WAS RE-DRESSED WITH AQUACEL EXTRA AND DRYMAX AND NO FURTHER ADHESION OR ODOR HAD BEEN OBSERVED. LASTLY, THE PATIENT IS BED-BOUND AND HIS USUAL ROUTINE HAD NOT BEEN DISTURBED DURING THE INITIAL TRIAL OF THE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226942 AQUACEL EXTRA HYDROPHILIC WOUND DRESSING KOZ CONVATEC LIMITED 420822 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention