BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1 PC - 1 PC UROSTOMY CONVEX POUCH W/DURAHESIVE (DH)

    MDR report key: 4101534 · Received August 19, 2014

    Report

    Report Number
    1049092-2014-10745
    Event Type
    Injury
    Date Received
    August 19, 2014
    Report Date
    June 11, 2012
    Manufacturer
    CONVATEC INC.
    Product Code
    EXH
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUES APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    END USER REPORTS THAT STARTING ABOUT 2 WEEKS AGO SHE DEVELOPED 3 AREAS THAT BLISTERED AND 2 OF THEM HAVE BROKEN LEAVING A SHALLOW ULCER WITH SERIOUS DRAINAGE NOTED. ONE IS AT 10 TO 11 O'CLOCK, ONE AT 12 O'CLOCK AND THE THIRD WITH BLISTER INTACT AT 1 TO 2 O'CLOCK. ALL THREE ARE DESCRIBED AS OVAL AND SMALLER THAN A DIME. THE OPEN AREAS HAVE A MOIST PALE PINK WOUND BED. THE BLISTER IS REPORTED AS CONTAINING A MILKY WHITE FLUID. THE END USER WAS SEEN BY HER DOCTOR WHO HAS PRESCRIBED BACTRIM BUT SHE REPORTS NO IMPROVEMENT. SINCE STARTING THAT SHE ALSO SAW ANOTHER DOCTOR WHO HAD HER USE NYSTATIN POWDER. NO NOTED IMPROVEMENT AS YET. FURTHER INFORMATION REGARDING PATIENT RESULTS WAS NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500264 ACTIVELIFE 1 PC - 1 PC UROSTOMY CONVEX POUCH W/DURAHESIVE (DH) BAG, URINARY, ILEOSTOMY EXH CONVATEC INC. 125365

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention