BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUACEL AG SURGICAL DRESSING

    MDR report key: 4924419 · Received July 14, 2015

    Report

    Report Number
    MW5044402
    Event Type
    Other
    Date Received
    July 14, 2015
    Date of Event
    July 1, 2015
    Report Date
    September 18, 2014
    Manufacturer
    CONVATEC
    Product Code
    FRO
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INCIDENT DESCRIPTION: SURGICAL DRESSING USED ON INCISION AFTER SURGERY HAS LEFT PERMANENT SCAR AND NERVE DAMAGE. ON (B)(6) 2014 I HAD A PARTIAL KNEE REPLACEMENT AT (B)(6) AMBULATORY SURGICAL CENTER, (B)(6) - DR. (B)(6), MD ATTENDING SURGEON. THE CONVATEC AQUACEL AG DRESSING WAS APPLIED IMMEDIATELY FOLLOWING THE SURGERY. I WAS RELEASED THAT SAME DAY AND WAS UNDER THE DAILY CARE OF (B)(6)). AS PER THE DOCTOR'S ORDER THE ATTENDING VISITING NURSE REMOVED THE AQUACEL AG DRESSING ON (B)(6) 2014. AT THIS TIME THE 1" X 2" OPEN FLESH WOUND WAS DISCOVERED. DAILY INSPECTION OF THE WOUND CAUSED CONCERN WITH THE NURSE WHO NOTIFIED THE SURGEON. I SENT THE SURGEON A PICTURE, WHICH HE THEN INSTRUCTED ME TO PUT A PRESCRIBED TOPICAL ANTIBIOTIC ON THE WOUND AND WANTED TO SEE ME IN PERSON THE NEXT DAY. AFTER PERSONAL INSPECTION THE SURGEON ALSO PRESCRIBED AN INTERNAL ANTIBIOTIC AS HE WAS WORRIED ABOUT THE PARTIAL REPLACEMENT BEING IN DANGER OF INFECTION BECAUSE OF THE WOUND CAUSED BY THE AQUACEL DRESSING. THE SURGEON WAS UNSURE WHY THE DRESSING HAD CAUSED THIS WOUND. HE HAD NEVER SEEN IT BEFORE. ON (B)(6) 2014 - SENT INITIAL EMAIL TO CONVATEC REGARDING THE PRODUCT AND THE WOUND ON MY LEG. I RECEIVED A REPLY PHONE CALL THE FOLLOWING DAY. I WAS TOLD IT WAS NOT AN ALLERGIC REACTION AS IT WOULD HAVE BEEN THE WHOLE SURFACE OF THE BANDAGE. THEY ASKED FOR PICTURES WHICH I SENT THE FOLLOWING DAY. ON (B)(6) 2015 - SENT AN EMAIL FOR AN UPDATE ON THE COMPLAINT. I DID NOT RECEIVE A REPLY. I CALLED ON (B)(6) 2015 AND WAS TOLD THE RESPONSES TAKE SEVERAL MONTHS TO PREPARE. ON (B)(6) 2015 I RECEIVED A LETTER FROM (B)(4), STATING BECAUSE NO SAMPLES WERE COLLECTED AND NO LOT # WAS PROVIDED THEY WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE "OPEN AREA" ON MY LEG. THE "OPEN AREA" HE REFERRED TO IS NOW A PERMANENT 1" X 2" SCAR WITH NERVE DAMAGE ON MY RIGHT LEG. ON (B)(6) 2015 I REPLIED WITH AN EMAIL ASKING IF I SHOULD CONSIDER THIS LETTER AS "CASE CLOSED". I HAVE HAD NO CORRESPONDENCE FROM THEM SINCE. IF THEY NEEDED LOT NUMBERS AND SAMPLES TO DETERMINE ROOT CAUSE, I EXPECTED THEY WOULD HAVE ASKED FOR IT. THIS WOUND TOOK AT LEAST 30 DAYS TO HEAL AND TO THE TOUCH, 9 MONTHS LATER, CONTINUES TO BE TINGLY, WHICH REFLECTS NERVE DAMAGE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457824 AQUACEL AG SURGICAL DRESSING SURGICAL DRESSING FRO CONVATEC

    Patients

    Seq Age Sex Outcome Treatment
    1