BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE

    MDR report key: 3960803 · Received June 10, 2014

    Report

    Report Number
    9618003-2014-00058
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE END USER STATED THE CORTISONE 2.5 PERCENT STEROID OINTMENT GIVEN HIM SOME RELIEF, ALTHOUGH THE RASH IS STILL THERE AND HIS APPLIANCE IS NOT STAYING ON FOR ONE FULL DAY, IN WHICH HE STATED WAS LIKELY DUE THE CREAM. THE END USER WAS EDUCATED O HOW TO APPLY THE CREAM, RUB IT INTO HIS SKIN, AND REMOVE THE OILY RESIDUE WITH A TISSUE THEN USE POWDER AND OR A PREP WIPE. IT WAS STATED THERE WAS A DISCUSSION WITH THE END USER REGARDING A POSSIBLE YEAST OR FUNGAL COMPONENT DUE TO THE INTRAVENOUS ANTIBIOTICS, TREATMENT WITH OVER-THE-COUNTER ANTI-FUNGAL POWDER AND HOW TO SEAL POWDER TO HIS SKIN WAS ALSO DISCUSSED. THE END USER STATED HE WILL CONTACT HIS DOCTOR IF THE OVER-THE-COUNTER POWDER DOES NOT RESOLVE THE ISSUE. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED.

    Description of Event or Problem · 1

    AN END USER STATED ON APPROX (B)(6) 2014 HE HAD TO PERFORM SEVERAL POUCH CHANGES (UNSPECIFIED AMOUNT AND WEAR TIME DURATION), BECAUSE THEY DID NOT LAST FOR HIS USUAL WEAR TIME OF FIVE DAYS. THE END USER STATED PRIOR TO THIS HE HAD BEEN IN THE HOSPITAL FOR SEPSIS AND REQUIRED INTRAVENOUS ANTIBIOTICS. THE END USER WENT ONTO STATE HE DEVELOPED A RED, ITCHY RASH UNDER TAPE BORDER AND UNDER MASS, WENT TO HIS DOCTOR ON (B)(6) 2014 AND WAS PRESCRIBED CORTISONE 2.5 PERCENT STEROID OINTMENT, WHICH HE STATED LED TO POOR ADHESION AND ADD'L FREQUENT POUCH CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337454 ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE POUCH, COLOSTOMY EZQ CONVATEC INC 022758 2J00922

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention