BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURASOL WOUND DRESSING NON-STERILE 3 OZ TUBE

    MDR report key: 4943451 · Received July 24, 2015

    Report

    Report Number
    1628114-2015-00001
    Event Type
    Death
    Date Received
    July 24, 2015
    Date of Event
    January 1, 2011
    Report Date
    June 29, 2015
    Manufacturer
    DPT LABORATORIES, LTD.
    Product Code
    MGQ
    PMA / PMN Number
    K921810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PASSED AWAY 4 YEARS AGO [DEATH]. CASE DESCRIPTION: ON (B)(6) 2015, A SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER REGARDING A FEMALE OF AN UNSPECIFIED AGE, WHO WAS BEING TREATED WITH CURASOL WOUND DRESSING NON-STERILE 3 OZ TUBE (DRESSING WOUND AND BURN, HYDROGEL). MEDICAL HISTORY INCLUDED COLOSTOMY AND ULCERS AROUND COLOSTOMY BAG CONCOMITANT PRODUCTS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PT STARTED TREATMENT WITH CURASOL WOUND DRESSING NON-STERILE 3 OZ TUBE AT AN UNSPECIFIED DOSE AND FREQUENCY TO ULCERS AROUND HER COLOSTOMY BAG. ON AN UNSPECIFIED DATE IN 2011 (REPORTED AS 4 YEARS AGO), AFTER STARTING THE PRODUCT, THE PT PASSED AWAY. THE REPORTER DECLINED TO PROVIDE ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482007 CURASOL WOUND DRESSING NON-STERILE 3 OZ TUBE MGQ DPT LABORATORIES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death