BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUACEL AG

    MDR report key: 499336 · Received December 4, 2003

    Report

    Report Number
    1049092-2003-00002
    Event Type
    Death
    Date Received
    December 4, 2003
    Date of Event
    November 12, 2003
    Report Date
    December 4, 2003
    Manufacturer
    CONVATEC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED 19% SCALD BURNS. FAMILY MEMBER OF THE PT WAS CARRYING A POT OF SOUP FROM ONE LOCATION IN THE KITCHEN TO ANOTHER. THE PT BUMPED INTO THE FAMILY MEMBER'S LEGS, CAUSING FAMILY MEMBER TO SPILL THE POT OF SOUP. PT WAS HOSPITALIZED FOR THEIR INJURIES. IN 2003 THE SUBJECT EXPERIENCED AN ELEVATED TEMPERATURE OF 41 DEGREES C. TWO DAYS LATER PT WAS FOUND IN THEIR HOSPITAL ROOM NOT BREATHING. RESUSCITATION MEASURES WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUACEL AG ANTIMICROBIAL WOUND DRESSING FRO CONVATEC * 2J59815

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death ATIVAN, CALCIUM GLUCONATE, ZANTAC.| MOTRIN, MG+ SILFATE K+ PHOSPHATE, 2003| IN 11/2003, KETAMINE. TYLENOL, MORPHINE,