BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1PC DRAINABLE POUCH W/STOMAHESIVE

    MDR report key: 3778215 · Received April 16, 2014

    Report

    Report Number
    9618003-2014-00040
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    February 15, 2014
    Report Date
    March 25, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THIS EVENT IS DEEMED A SERIOUS INJURY. THE END USER STATED HE SAW HER DOCTOR WHO DIAGNOSED HER WITH A YEAST OR FUNGAL INFECTION AND PRESCRIBED LOTRIMIN POWDER TO BE APPLIED USING CAVILON NO STING SPRAY. THE END USER STATED THE RASH DID GET BETTER, BUT KEEPS COMING BACK. THE END USER WAS ADVISED TO CONTACT HER DOCTOR AND SEE IF NYSTATIN POWDER MAY BE MORE EFFECTIVE. THE END USER WAS ALSO ADVISED TO CONTINUE TREATMENT FOR A WEEK OR TWO AFTER RASH HAS CLEARED. IT WAS DISCUSSED WITH THE END USER THAT A PATCH TEST TO CHECK FOR TAPE SENSITIVITY MAY BE NEEDED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(4), 2014.

    Description of Event or Problem · 1

    AN END USER REPORTED A RED ITCHY RASH MOSTLY UNDER TAPER BORDER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233516 ACTIVELIFE 1PC DRAINABLE POUCH W/STOMAHESIVE POUCH, COLOSTOMY EZQ CONVATEC INC. 022766 3A00236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention