BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/STOMAHESIVE(SH)

    MDR report key: 4121356 · Received September 19, 2014

    Report

    Report Number
    9618003-2014-10170
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 11, 2011
    Report Date
    August 12, 2011
    Manufacturer
    CONVATEC INC
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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(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. A BATCH RECORD REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE FOUND RELATED TO THE COMPLAINT. RETAINED PRODUCT WAS EVALUATED AND APPEARED TO BE IN NORMAL CONDITION. A REVIEW OF COMPLAINT TREND FOR THE PREVIOUS 12 MONTHS WAS PERFORMED AND THERE IS NO INDICATION OF A COMPLAINT TREND.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE END USER STATES THAT SHE EXPERIENCED ITCHING UNDER THE BORDER FOR FOUR MONTHS. THE END USER HAS ALWAYS PURCHASED THE SAME PRODUCT AND THE ITCHING UNDER THE BORDER HAS NEVER HAPPENED BEFORE. THE PTS SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583475 ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/STOMAHESIVE(SH) POUCH, COLOSTOMY EZQ CONVATEC INC 022771 0F03068

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention