BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ DURAHESIVE (DH)

    MDR report key: 4083765 · Received August 22, 2014

    Report

    Report Number
    1000317571-2014-11116
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    August 1, 2012
    Report Date
    November 28, 2012
    Manufacturer
    CONVATEC INC
    Product Code
    EZQ
    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 ISSUED APRIL 16 2014. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. AND ADDITIONAL INFO 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 (B)(6) 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

    REPORT RECEIVED BY THE END USER STATES THAT THEY ARE EXPERIENCING A RED, OPEN, WEEPY AND ITCHY RASH UNDER THE MASS. THE END USER EXPERIENCED THE CONDITION DURING A PERIOD OF THREE TO FOUR MONTHS PRIOR TO COMPLAINT RECEIPT. THE END USER CONSULTED HIS PHYSICIAN AND IN TURN WAS PRESCRIBED AN OSTOMY POWDER. THERE HAS BEEN A SIGNIFICANT IMPROVEMENT. THE PERISTOMAL SKIN IS NOW RED AND INTACT WITH NO RASH OR ITCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508367 ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ DURAHESIVE (DH) EZQ CONVATEC INC 175778

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention