BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUACEL AG

    MDR report key: 628436 · Received August 18, 2005

    Report

    Report Number
    1049092-2005-00047
    Event Type
    Other
    Date Received
    August 18, 2005
    Date of Event
    July 18, 2005
    Report Date
    August 18, 2005
    Manufacturer
    CONVATEC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN CALLED FOR ADVICE REGARDING ONE OF HIS PATIENTS. THE PT HAS NECROTISING FACIITIS COVERING A LARGE AREA INCLUDING THEIR PERINEUM. THIS AREA HAS BEEN SURGICALLY DEBRIDED AND AQUACEL AG IS BEING USED AS THE PRIMARY DRESSING, 304 PIECES OF (10CM X 10CM) ARE BEING USED AT EACH DRESSING CHANGE. THE PATIENT IS BEING TREATED WITH SYSTEMIC ANTIBIOTICS. PHYSICIAN IS CONCERNED THAT THE PATIENTS LFTS (LIVER FUNCTION TESTS) ARE ELEVATED. HE HAS REVIEWED THE PATIENTS CHARTS/NOTES AND CAN FIND NO OBVIOUS REASON FOR THIS. HE IS CONCERNED THAT IT MAY BE DUE TO AQUACEL AG AND TO THIS EFFECT HE HAS DISCONTINUED THE USE OF THE PRODUCT. CO DISCUSSED WITH THE PHYSICIAN THAT AQUACEL AG CONTAINS LOW LEVEL OF IONIC SILVER AND THAT THE DRESSING IS DESIGNED NOT TO DEPOSIT SILVER INTO THE WOUND, BUT RETAINS THE SILVER AT THE WOUND-DRESSING INTERFACE. THEREFORE, MINIMAL CHANCE THAT THE SILVER WILL BE ABSORBED SYSTEMICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUACEL AG WOUND DRESSING FRO CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other