BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL EXTRA

    MDR report key: 3884081 · Received June 9, 2014

    Report

    Report Number
    1000317571-2014-00036
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    March 3, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CONVATEC LIMITED
    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 THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. ADD'L INFO RECEIVED VIA EMAIL DATED (B)(6) 2014 IS STATED AS FOLLOWS: "FINALLY I HAVE THE INFO FROM (B)(6) NURSING HOME REGARDING THE PTS ON WHOM THE AQUACEL STUCK. THERE ARE SOME DETAILS SHE EITHER COULDN'T OR WOULDN'T GIVE TO ME, AND ONE OF THE PTS DIED OF AN UNRELATED ISSUE SOME TIME AGO, AND THEIR FILE HAS BEEN CLOSED AND 'SENT OFF' SO SHE NO LONGER HAS ACCESS TO THE INFO. THE INCIDENTS APPARENTLY HAPPENED AT THE BEGINNING OF MARCH, BUT I DIDN'T FIND OUT ABOUT THEM UNTIL MY LAST VISIT ON THE (B)(6). THE NURSE COULD ONLY TALK TO ME FOR 10 MINS AS SHE WAS STILL VERY BUSY. THE NURSE WAS NOT ABSOLUTELY SURE, BUT SAID THE DRESSINGS WERE APPLIED IN THE WEEK FOLLOWING MY VISIT ON THE (B)(6), WHICH COULD MEAN THE DRESSINGS WERE APPLIED IN THE WEEK BEGINNING (B)(6)". 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. 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 PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT SAMPLES OF AQUACEL EXTRA, AQUACEL HEEL FOAM AND NON ADHESIVE AQUACEL FOAM WAS PROVIDED TO THE NURSING HOME TO USE ON PT'S LEG ULCERS. FEEDBACK PROVIDED FROM COMPLAINANT INDICATED THAT THEY HAD STOPPED USING THE DRESSINGS BECAUSE THEY HAD FOUND THEM TO STICK TO THE LEG ULCER WOUNDS OF 2 DIFFERENT PTS. THEY HAD USED THE AQUACEL EXTRA AND AQUACEL FOAM TOGETHER (NO OTHER FOAM WAS USED) AND BANDAGING TO HOLD THE DRESSINGS IN PLACE AND THE ULCERS WERE MODERATELY EXUDATING. THE NURSE ONLY TRIED THE DRESSINGS ONCE AND THEN DISCONTINUED USE OF AQUACEL EXTRA, GOING BACK TO USING INADINE WITH BIATAIN, FOR THE GEL THAT HAD FORMED WITH EXUDATES FROM THE WOUNDS HAD DRIED AND HARDENED WHICH WAS VERY DIFFICULT TO REMOVE RESULTING IN EXTREME PAIN TO PT. LASTLY, THE PT WAS PROVIDED TREATMENT TO LEG ULCERS ON THREE (3) SEPARATE AREAS ON LEFT LEG, MODERATELY EXUDATING - EACH COVERED BY A 10X10 AQUACEL EXTRA DRESSING WITH A 15X20 NON-ADHESIVE SECONDARY DRESSING. NOTE: THIS REPORT IS RELATED PT IDENTIFIER(S); (B)(6) REPORTED UNDER MFR'S REPORTS: 1000317571-2014-00033, 1049092-2014-00171, 00209 RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335328 AQUACEL EXTRA HYDROPHILIC WOUND DRESSING, 79NAC NAC CONVATEC LIMITED 420672 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention